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Study 

Implications of 
Advances in 
Biomedical and 
Behavioral 
Research 

Report and Recommendations 
of the National Commission for 
the Protection of Human Subjects 
of Biomedical and Behavioral 
Research 


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Special 

Study 

Implications of 
Advances in 
Biomedical and 
Behavioral 
Research 

Report and Recommendations 
of the National Commission for 
the Protection of Human Subjects 
of Biomedical and Behavioral 
Research 




DHEW Publication No. (OS) 78-0015 





National Commission for the Protection of Human Subjects 
of Biomedical and Behavioral Research 

Westwood Building, Room 125 
5333 Westbard Avenue 
— Bethesda, Maryland 20016 

September 30, 1978 


The President 
The White House 
Washington, D.C. 20500 


Dear Mr. President: 


On behalf of the National Commission for the Protection of Human 
Subjects of Biomedical and Behavioral Research, I am pleased to trans- 
mit our report on the "Special Study: Implications of Advances in Bio- 
medical and Behavioral Research. " This is one of several studies that 
the Commission was directed to undertake in its mandate under Public 
Law 93-348, which also directs the Commission to submit its reports 
to the President, the Congress, and the Secretary of Health, Education, 
and Welfare. 


Of all the topics assigned to the Commission, the Special Study was 
the most far -ranging; however, because of constraints of time and other 
responsibilities, the Commission was forced to deal with this topic in 
great generality. More specific results would have been obtained from 
a more specific assignment, such as the ethical, social and legal impli- 
cations of a particular advance in technology. Although we provide only 
general conclusions in the Special Study, the success of the Comission 
in other areas of its mandate is evidence of the usefulness of a com- 
mission in developing advice in response to a specific assignment. 

Thus, the Commission itself is a demonstration of the validity of 
its conclusion in the Special Study that an advisory commission should 
be established to anticipate the probable effects of research and tech- 
nological advances and to stimulate public participation in the decision 
making. We hope that our report and the accompanying documents that 
were prepared under contract to the Commission will assist the present 
debate on the need to establish a successor advisory commission. 

We appreciate the opportunity to have worked on this topic of great 
importance to the nation. 











National Commission for the Protection of Human Subjects 
of Biomedical and Behavioral Research 


Westwood Building, Room 125 


5333 Westbard Avenue 
Bethesda, Maryland 20016 


September 30, 1978 


The Honorable Walter F. Mondale 
President of the United States Senate 
Washington, D.C. 20510 

Dear Mr. President: 

On behalf of the National Commission for the Protection of Human 
Subjects of Biomedical and Behavioral Research, I am pleased to trans- 
mit our report on the "Special Study: Implications of Advances in Bio- 
medical and Behavioral Research. " This is one of several studies that 
the Commission was directed to undertake in its mandate under Public 
Law 93-348, which also directs the Commission to submit its reports 
to the President, the Congress, and the Secretary of Health, Education, 
and Welfare. 

Of all the topics assigned to the Commission, the Special Study was 
the most far -ranging; however, because of constraints of time and other 
responsibilities, the Commission was forced to deal with this topic in 
great generality. More specific results would have been obtained from 
a more specific assignment, such as the ethical, social and legal impli- 
cations of a particular advance in technology. Although we provide only 
general conclusions in the Special Study, the success of the Comission 
in other areas of its mandate is evidence of the usefulness of a com- 
mission in developing advice in response to a specific assignment. 

Thus, the Commission itself is a demonstration of the validity of 
its conclusion in the Special Study that an advisory commission should 
be established to anticipate the probable effects of research and tech- 
nological advances and to stimulate public participation in the decision 
making. We hope that our report and the accompanying documents that 
were prepared under contract to the Commission will assist the present 
debate on the need to establish a successor advisory commission. 

We appreciate the opportunity to have worked on this topic of great 
importance to the nation. 



Kenneth J. Ryan, M. D. 
Chairman 



National Commission for the Protection of Human Subjects 
of Biomedical and Behavioral Research 

Westwood Building, Room 125 
5333 Westbard Avenue 

■ — ~ 1 • -= -■■:■ 11 . ... . ; Bethesda, Maryland 20016 

September 30, 1978 


The Honorable Thomas P. O'Neill, Jr. 
Speaker of the House of Representatives 
Washington, D.C. 20515 


Dear Mr. Speaker: 

On behalf of the National Commission for the Protection of Human 
Subjects of Biomedical and Behavioral Research, I am pleased to trans- 
mit our report on the "Special Study: Implications of Advances in Bio- 
medical and Behavioral Research. " This is one of several studies that 
the Commission was directed to undertake in its mandate under Public 
Law 93-348, which also directs the Commission to submit its reports 
to the President, the Congress, and the Secretary of Health, Education, 
and Welfare. 

Of all the topics assigned to the Commission, the Special Study was 
the most far -ranging; however, because of constraints of time and other 
responsibilities, the Commission was forced to deal with this topic in 
great generality. More specific results would have been obtained from 
a more specific assignment, such as the ethical, social and legal impli- 
cations of a particular advance in technology. Although we provide only 
general conclusions in the Special Study, the success of the Comission 
in other areas of its mandate is evidence of the usefulness of a com- 
mission in developing advice in response to a specific assignment. 

Thus, the Commission itself is a demonstration of the validity of 
its conclusion in the Special Study that an advisory commission should 
be established to anticipate the probable effects of research and tech- 
nological advances and to stimulate public participation in the decision 
making. We hope that our report and the accompanying documents that 
were prepared under contract to the Commission will assist the present 
debate on the need to establish a successor advisory commission. 

We appreciate the opportunity to have worked on this topic of great 
importance to the nation. 







National Commission for the Protection of Human Subjects 
of Biomedical and Behavioral Research 

Westwood Building, Room 125 
5333 Westbard Avenue 

■ — =. •= ■ — ■ = --■■■: — Bethesda, Maryland 20016 

September 30, 1978 


Honorable Joseph A. Califano, Jr. 

Secretary of Health, Education, and Welfare 
Washington, D.C. 20201 


Dear Mr. Secretary: 

On behalf of the National Commission for the Protection of Human 
Subjects of Biomedical and Behavioral Research, I am pleased to trans- 
mit our report on the Special Study: Implications of Advances in Bio- 
medical and Behavioral Research. This is one of several studies that 
the Commission was directed to undertake in its mandate under Public 
Law 93-348, which also directs the Commission to submit its reports 
to the President, the Congress, and the Secretary of Health, Education, 
and Welfare. 

Of all the topics assigned to the Commission, the Special Study was 
the most far-ranging; however, because of constraints of time and other 
responsibilities, the Commission was forced to deal with this topic in 
great generality. More specific results would have been obtained from 
a more specific assignment, such as the ethical, social and legal impli- 
cations of a particular advance in technology. Although we provide only 
general conclusions in the Special Study, the success of the Comission 
in other areas of its mandate is evidence of the usefulness of a com- 
mission in developing advice in response to a specific assignment. 

Thus, the Commission itself is a demonstration of the validity of 
its conclusion in the Special Study that an advisory commission should 
be established to anticipate the probable effects of research and tech- 
nological advances and to stimulate public participation in the decision 
making. We hope that our report and the accompanying documents that 
were prepared under contract to the Commission will assist the present 
debate on the need to establish a successor advisory commission. 

We appreciate the opportunity to have worked on this topic of great 
importance to the nation. 




NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS 
OF BIOMEDICAL AND BEHAVIORAL RESEARCH 


MEMBERS OF THE COMMISSION 


Kenneth John Ryan, M.D., Chairman 

Chief of Staff 

Boston Hospital for Women 


Joseph V. Brady, Ph.D. 

Professor of Behavioral Biology 
Johns Hopkins University 


Robert E. Cooke, M.D. 

President 

Medical College of Pennsylvania 


Dorothy I. Height 

President 

National Council of Negro Women, Inc. 


Albert R. Jonsen, Ph.D. 

Associate Professor of Bioethics 
University of California at San Francisco 


Karen Lebacqz, Ph.D. 

Associate Professor of Christian Ethics 
Pacific School of Religion 


* David W. Louisell, J.D. 

Professor of Law 

University of California at Berkeley 


Donald W. Seldin, M.D. 

Professor and Chairman 
Department of Internal Medicine 
University of T exas at Dallas 

Eliot Stellar, Ph.D. 

Provost of the University and 
Professor of Physiological Psychology 
University of Pennsylvania 


Patricia King, J.D. 

Associate Professor of Law 
Georgetown University Law Center 


* Robert H. Turtle, LL.B. 

Attorney 

VomBaur, Coburn, Simmons & Turtle 
Washington, D.C. 


Deceased 


NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS 
OF BIOMEDICAL AND BEHAVIORAL RESEARCH 


COMMISSION STAFF 


PROFESSIONAL STAFF 

Michael S. Yesley, J.D. 

Staff Director 

Barbara Mishkin, M.A. 
Assistant Staff Director 

Duane Alexander, M.D. 
Pediatrics 

Tom L. Beauchamp, Ph.D. 
Philosophy 

Bradford H. Gray, Ph.D. 
Sociology 

Miriam Kelty, Ph.D. 
Psychology 

Betsy Singer 

Public Information Officer 

Dorle Vawter 

Research Assistant 


SUPPORT STAFF 
Pamela L.'Driscoll 
Marie D. Madigan 
Coral M. Nydegger 
Erma L. Pender 

SPECIAL CONSULTANTS 
Robert J. Levine, M.D. 
Stephen Toulmin, Ph.D. 




TABLE OF CONTENTS 


I. The Mandate 1 

II. Activities Sponsored by the Commission 4 

III. Findings With Implications for Public Policy. ... 6 

IV. Recommendations 9 

APPENDIX A : 

A Comprehensive Study of the Ethical, Legal, and Social 
Implications of Advances in Biomedical and Behavioral 
Research and Technology 


APPENDIX B: 


Scholarly Adjunct 



I. The Mandate 


The National Commission for the Protection of Human Subjects was directed 
under section 203 of Public Law 93-348 to conduct a "special study" of the eth 
cal, social and legal implications of advances in biomedical and behavioral re 
search and technology. The issues reflected in the special study go back at 
least to 1945 (the year of Hiroshima) and have continued to develop in signif- 
icant ways since Public Law 93-348 was enacted in July 1974. Since the last 
century, but most markedly from the time of World War II, advances in science 
and technology have been influencing the character of social and individual 
life. Such advances have created problems not only on account of their imme- 
diate consequences, but also because of their side effects. Questions have 
been raised regarding issues that range from "tampering with nature" to inva- 
sion of privacy. In addition, the complexity of scientific and technological 
issues has placed a strain on governmental machinery, most notably in democra- 
tic societies and nations where public participation and understanding have 
important roles to play in the formation of policy. In addressing section 203, 
accordingly, the immediate problems of biomedical and behavioral research and 
technology must be considered in relation to broader aspects of social change 
and public policy. 

The recognition by then Senator Walter Mondale that the impact of biomed- 
ical and behavioral science and technology was more widespread and had given 
rise to more public disquiet than had been properly appreciated led him to 
sponsor S.J, Res. 145 in 1968 and S.J, Res. 75 in 1971, resolutions from which 


2 


section 203 of Public Law 93-348 was derived. Similar considerations were 
responsible for a series of additional steps and inquiries in the government 
and elsewhere during the 1970s. 

In the Congress, the Office of Technology Assessment, established in 
1972, has conducted inquiries into the impact of certain innovations in 
medical technology and services. Related areas have been studied by other 
divisions of the Congress, including the staffs of the relevant House and 
Senate subcommittees, the General Accounting Office, and the Congressional 
Clearinghouse on the Future in the Legislative Reference Service of the 
Library of Congress. 

At the National Academy of Sciences, the Academy of Engineering and the 
Institute of Medicine have studied the medical and nonmedical impacts of some 
innovations. Within DHEW, an Office of Health Technology has recently been 
established to coordinate analysis and testing by agencies of efficacy and 
safety, cost effectiveness, and standards of development for new and existing 
technologies, and to assist in determing which intervention mechnisms should 
be used to promote, inhibit or control the development and use of technologies. 
The National Institutes of Health has established an Office for the Medical 
Applications of Technology and has also been seeking to extend the roles of 
the National Advisory Councils to enlarge the contribution of public repre- 
sentatives to the development of research policies and priorities. The 
establishement of local Professional Standards Review Organizations and 
Health Systems Agencies provides new mechanisms for involving members of 
the professional community and lay public in monitoring the health care 


3 


delivery system, including such new technologies as computerized tomography. 
The Bureau of Health Planning and Resources Development is sponsoring a 
study, mandated by Public Law 93-641, on technological advances in health 
planning. 

Similarly the reintroduction of science policy advisers into the 
Executive Office of the President, through the creation of the Office for 
Science and Technology Policy in 1976, could play a part in the development 
of public policies in the area of section 203. 

Each of these assessment activities has its own goal, and none of them 
attends exclusively and explicitly to the ethical, social and legal implica- 
tions of advances in technology. While the various mechanisms have been per- 
forming in their own spheres, there has been a demonstrable increase in 
interest in careful review of the implications of new technologies. 

The most striking episode to take place in the area of the Special Study 
since the enactment of Public Law 93-348 has been controversy over recombinant 
DNA research. The broad concern over such research was almost totally unfore- 
seen, even by the scientists most closely involved. This controversy demon- 
strated the range and depth of public disquiet and political feeling that can 
be aroused by the prospect of seemingly drastic new biomedical or behavioral 
influences on society originating in branches of science too technical for 
the public to understand. Whether or not, in fact, recombinant DNA research 
involves so grave a threat to the public health as some participants have 
maintained, the debate has made it clear that a better system of early 
warning and monitoring is required. Novel developments likely to result 


4 


from projected biomedical and behavioral research should be identified 
and assessed systematically before they arouse public alarm and political 

passions. 

II. Activities Sponsored by the Commission 

A request for proposals, which reiterated the language of section 203, 
was published in the Commerce Business Daily in February 1975. Proposals 
received were evaluated by a technical review panel which recommended that a 
contract be awarded jointly to Policy Research Incorporated and the New Jersey 
Institute of Technology ( PRI/NJ IT ) to conduct an iterative policy study in- 
volving a national panel of consultants. Two other projects were implemented 
simultaneously. One was a national opinion survey to serve as an adjunct to 
the policy study. The other, recommended by the technical review panel as 
an alternative approach to the mandate, was a four-day colloquium of twenty- 
five scientists and scholars. A core group of the participants prepared a 
report of the colloquium. 

The reports to the Commission that resulted from these different pro- 
jects (reprinted in the Appendix to this statement) involved very different 
approaches to the special study. The PRI/NJ IT policy study used a dynamic 
communication technique designed to analyze value-laden policy-related 
content. It consisted of a structured, iterative inquiry mailed to and 
completed by 121 consultant panelists between February and August 1976. 

Each successive inquiry instrument was based on responses to the preceding 
one. Panelists were thus provided feedback and were able to compare and 
contrast their own views with those of others. The study design relied 


5 


heavily on a policy Delphi technique that sought to synthesize divergent 
positions advocated by respondents. Anonymity was protected, panelists 
had the opportunity to modify their positions, and different positions on 
issues were presented. Five subject areas were selected with the expecta- 
tion that advances in those areas would generate a broad range of ethical, 
legal and social concerns during the next twenty years. 

The national opinion survey was designed to elicit public attitudes 
toward advances in biomedical and behavioral research technology and 
alternative policies to deal with them. A structured questionnaire was 
administered to a random sample of 1,679 noninstitutionalized adults in the 
continental U.S. A parallel version of the questionaire was administered 
to the Delphi panelists, and the responses of the public and the panel were 
compared and contrasted. 

The colloquium developed an historical and sociological perspective on 
recent advances in biomedical and behavioral research and services using a 
case study method. The social impact of advances was explored, as were 
existing legal and institutional constraints and incentives governing the 
introduction of new technologies into medical practice. In addition, cur- 
rent knowledge about the public's understanding of and attitudes toward 
advances and their implications was reviewed. 

In general, these different approaches yielded similar results. The 
immediate consequences of the scientific and technological advances in 
biomedical and behavioral research and services since World War II are per- 
ceived, for the most part, as beneficial by professionals and the lay public. 


6 


Neither group fears that the scale and character of the advances to be 
expected over the next few decades will change so drastically as to in- 
validate this optimistic assessment. Some of the anxieties expressed in 
the legislative hearings on the original Mondale resolution, and more 
recently in the recombinant DNA debate, appeared to both groups of the 
Commission's respondents to have been exaggerated. If immediate action is 
called for at the present time, both groups agreed, it will chiefly be to 
create new institutions to monitor the development and introduction of new 
technologies in the biomedical and behavioral fields, and to draw the 
attention of legislatures and the public to social problems arising from 
the use of these new technologies. 

Some of these resulting social problems are already apparent, and 
the kinds of measures required to deal with them are discussed below. But 
it is probably worth underlining that, among all of the Commission's re- 
spondents, no significant body of opinion emerged that was opposed to con- 
tinuation of the scientific and technological research that has led to so 
many innovations since 1945. Still less was there significant support for 
anything resembling a mori tori urn on biomedical and behavioral research. 

On the contrary, there was widespread consensus that, for the foreseeable 
future as for the past, the advantages flowing from such research will 
continue to outweigh the incidental problems resulting from them. 

III. Findings With Implications for Public Policy 

Several broad findings may be derived from the policy study, public 
opinion survey and the report of the colloquium sponsored by the Commission 


7 


that are generally consistent with other literature addressing similar 
problem areas. 

1. Today most Americans view scientific advances and technological 
innovations positively. However, there is growing recognition among the 
public, the scientific community and government officials that societal 
problems are increasingly complex and that the application of advances and 
innovations in biomedical and behavioral research and technology should 
take into account not only scientific and technological factors, but also 
their social context and the extent to which society can accommodate these 
advances. 

2. Value conflicts are an inevitable consequence of the tensions 
in a pluralistic society between competing committment to personal free- 
dom and social responsibility, privacy and the public need for information, 
and the degree to which citizens should be protected by government. 

Behind these diverse concerns lie quite different views of the human image, 
of the nature of state authority, and of the form of the public welfare. 

The ethical concerns raised by advances in biomedical and behavioral 
technology reflect not only the novelty of these advances, but the deeper 
uncertainty and diversity of social values. Any public policy about these 
advances must respect the plurality of social values. Solutions which are 
reached in a democratic manner must genuinely protect the welfare of in- 
dividuals and communities. 

3. Situations in which the introduction of new technology could be 
of considerable benefit to some individuals, but only at the expense of 


8 


others, create problems of equity. Often technological innovations are 
initially available only at high cost due to the expense of development 
and the apparatus involved. If public funds are used to make these new 
technologies available, decisions must be made regarding which individuals 
should benefit, and how to allocate benefits when resources are limited. 

There is a need to address the problem of equity of access to the benefits 
of innovations and the problems surrounding the allocation of limited re- 
sources. 

4. The lack of understanding of the details of scientific developments 
and the feeling that decisions are made by depersonalized government agencies 
lead to an erosion of trust by the public. Research activities, including 
funding mechanisms, should be accessible to the public to enhance general 
understanding of developing knowledge. Mechanisms should be developed both 
to educate the general public and to encourage its participation in making 
value decisions. Scientists should be sensitive to concerns of the general 
publ ic. 

5. There is a recognition that the introduction of new technologies 
may have unanticipated and unwanted side effects detrimental to the health 
of individuals, and that mechanisms need to be developed to protect against 
such hazards. There should be an early warning system in which there is an 
assessment of potential secondary impacts prior to the dissemination of new 
technologies. The results of such technological assessments should be 
widely available to the public to provide a knowledge base for decision 
making and to enhance public participation in the development of policy. 


9 


IV. Recommendations 

The Commission's findings that have implications for public policy 
cluster in two areas: one set of findings indicates a perceived need 

for a program to assess the social impact of technology. The second sug- 
gests a need to facilitate public information and public participation 
in research and technological innovations and the policy decisions that 
result. These findings suggest that a mechanism should be established to 
monitor and evaluate innovations and to provide an early warning system 
in which the probable effects of innovations in biomedical and behavioral 
research and technology can be assessed publicly, prior to development or 
widespread dissemination. The existing entities referred to previously 
serve narrower constituencies and goals, and the independence and broader 
mandate of a new body are needed. 

The establishment of a mechanism to encourage public participation 
in policy formulation was of special concern to Mr. Mondale who, during 
legislative hearings on the resolution to establish a Commission on Health 
Science and Society in 1971, said that studies of advances and their impli- 
cations should be incorporated into a public process by which society might 
express its right to say something about its own future: "The public's 

stake is too great. And the need for consensus as to how society should 
deal with these profound problems is too clear ... I think we need some- 
thing far more official and far more public if we are to reach agreement on 
the ways in which society is to organize itself to handle these unprecedented 
problems . " 


10 


The National Commission for the Protection of Human Subjects recommends, 
as have Mr. Mondale and Senator Kennedy, that an advisory commission be em- 
ployed to anticipate the probable effects of research and technological ad- 
vances for individuals and society, and to stimulate public participation 
in decision making. A commission with diverse membership, independent of 
control by any government agency or private institution, would be able to 
examine issues without the customary institutional and political constraints. 
The commission should not be dominated by health professionals, for its main 
purpose would be to facilitate widespread debate involving all segments of 
society in the ethical and policy issues that affect all people and about 
which diverse views should be heard. The commission would be able to 
clarify many issues and foster better understanding by the public and by 
those directly involved in decision making. It would not itself decide 
issues but rather help society to decide who should decide them and to 
explore the implications of various decisions that may ensue. 


APPENDIX A 


A COMPREHENSIVE STUDY OF THE ETHICAL, 
LEGAL, AND SOCIAL IMPLICATIONS OF 
ADVANCES IN BIOMEDICAL AND BEHAVIORAL 
RESEARCH AND TECHNOLOGY 

FINAL REPORT 
July 1977 


Policy Research Incorporated 
2500 North Charles Street 
Baltimore, Maryland 21218 


Center for Technology Assessment 
New Jersey Institute of Technology 
323 High Street 
Newark, New Jersey 07102 


Contract No. N01 -HU-6-21 05 
Copyright, Policy Research Incorporated 1977 


(printed under license to the government) 





i 


PREFACE 



This special study was mandated by the U.S. Congress under 
Section 203 of PL 93-348, The National Research Act. It was 
conducted under contract N01-HU-6-2105 for the National Commis- 
sion for the Protection of Human Subjects of Biomedical and 
Behavioral Research. The study began in September 1975 and 
was completed in January 1977. 

Study 
Furpose 
and Methods 

The major purpose of the study was to analyze and evaluate: 

* the implications of advances in biomedical and 
behavioral research and technology; 

* the implications of policies to deal with such 
research and the implementation of resultant 
technologies; and 

* public understanding and attitude toward these 
matters . 

The special study consisted of two components: (1) a 

policy study; and (2) a national opinion survey, an adjunct 
to the policy study suggested by the study’s designers as 
necessary to meet the Congressional mandate. 

Contents , 
Layout of 
the Report 

This report contains the findings of the policy study and the 
national opinion survey, and the study conclusions. A complete 
list of the study products is shown at the end of the Preface. 

This report consists of six chapters, and six appendices. 

A detailed table of contents has been provided to allow readers 
to find sections of particular interest. All tables, graphs, 
and other figures have been placed at the end of each chapter 
to avoid interrupting the text, and to facilitate locating them 


Throughout the report titles of subject areas, advances, seen- 


11 


arios, and effects of advances have been italicized for the 
convenience of the reader. 

Insofar as possible, a common layout has been adopted for 
each chapter and each chapter has been divided into several 
distinct sections. The content of each chapter is summarized 
below. 

Chapter 1, Introduction , Summary _, and Conclusions > provides 
a context for the study, describes the mandate, and summarizes 
the study methods and findings. Conclusions about advances and 
policies are also presented. This chapter has been circulated 
widely as a separate document to people who want only an appre- 
ciation of the study. 

The next two chapters deal with advances in biomedical and 
behavioral research and technology, and their implications. 
Chapter 2, Advances _, outlines the methods used to select the 
subject areas for the study, develop the advances for each sub- 
ject area, and identify the implications of advances. Findings 
are reported, by subject area, according to a common outline: 

(1) the particular advances that were considered in a subject 
area are listed; (2) the pertinent findings are described, in- 
cluding the dimensions that underlay panelists' responses; and 
(3) a brief analysis and evaluation of the findings is pre- 
sented. 

Chapter 3, Implications of Advances _, addresses the impli- 
cations of advances more broadly, assessing the manner in which 
biomedical and behavioral advances will influence individuals 
and society. This chapter is divided into three sections, 


iii 


prefaced by a brief methodological note. These sections are: 
implications for individuals, implications for society, and 
moral and ethical issues. 

Chapters 4 and 5 deal with policies which might be imple- 
mented to control or direct biomedical and behavioral research 
and the implementation of resultant technologies, and the impli- 
cations of these policies. Chapter 4, Policies j reviews the 
methods used to identify policies for specific advances, general 
policy statements, and a possible comprehensive national policy, 
and presents the study findings. As in earlier chapters, the 
findings are presented in a common outline consisting of a 
section on findings and a subsequent analysis and evaluation. 

Chapter 5, Implications of Policies _, provides a brief 
methodological note as an introduction to a general discussion 
of the implications of possible comprehensive national policy 
for biomedical and behavioral research and technology. This 
chapter deals with the implications of policies under five head- 
ings: need for controls; the role of government; justice; 

economic factors; and public participation. 

Chapter 6, the final chapter is on Public Understanding 
and Attitude. This chapter reports the findings of the national 
opinion survey and compares and contrasts panelists' responses 
to questionnaire items with those of the public. The format 
for this chapter parallels that for earlier chapters on advances 
and policies; findings are followed by a brief analysis and 


evaluation. 


XV 


Assessment In an area in which a person's view of "what is" merges subtly 

of the 

Study with "what should be", the process used to carry out a study to 

Method 

assess technological advancement may be as important as findings 
that result from that process. At present, there are no standard 
methods for systematically assessing technologies, the implica- 
tions of technologies, or the implications of policies designed 
to regulate the development and implementation of technologies. 
Consequently, this study itself may be viewed as an innovation. 
Its novel features included: adversary assessments, two opposed 

groups arguing the pros and cons of their position; an assess- 
ment of the negative consequences that would result from imple- 
menting a policy one dislikes; and asking both experts and the 
general public the same questions, and comparing the results. 

The dynamic communication technique developed by Policy 
Research Incorporated lent itself well to this endeavor. By 
using a series of three insti'uments, the study team was able to 
produce pro and contra arguments which form the basis of various 
policy alternatives, resource allocation alternatives, outcomes, 
impacts and effects. The anonymity of the participants was pro- 
tected, and each panelist was given a chance to modify his or 
her positions. The method allowed for the presentation of a num- 
ber of different positions on issues and handled even intense 
disagreement without polemic. 

Based on the results of this study, it would seem fruitful 
to apply this dynamic communication technique to other complt , 
ill-structured, and value-laden areas of national policy. In 
addition, the results of this study would suggest that a national 


V 


Development 
of the 
Study 
Findings 


survey of public opinion is a valuable adjunct to any policy 
study. By comparing and contrasting the views of experts with 
those of the general public similarities and differences in opin- 
ions and values between experts and public can be identified, 
providing the policy-maker with more complete information with 
which to make decisions. 

The policy study which forms the central part of the special 
study used an iterative approach with a series of three Policy 
Evaluation Instruments (PEIs). These instruments were used to 
collect information about specific advances in biomedical and 
behavioral research and technology and about policies to deal 
with these advances. Using this method massive amounts of 
data were generated. The verbatim transcripts of panelists’ 
responses to the PEIs amount to literally millions of words. 

The summaries of these responses alone total well over 1,000 
pages. This report represents a distillation of those responses. 

The study findings — the analyses and evaluations of 
advances, policies, and their implications — presented in this 
report represent the opinions of the 121 consultant panelists who 
completed PEIs, and the opinions of a probability sample of 1,679 
Americans who responded to the national opinion survey. The 
findings of the study do not necessarily represent the views of 
the Study Design and Management Group, or of other members of 
the study team, or those of the Commission. Our purpose has 
been to report accurately the points of view expressed by the 


panel and the public. 


In the design and conduct of the study we 


VI 


Cautions 
to the 
Reader 


have gone to considerable lengths to insure that what is reported 
accurately reflects what was said. 

Finally, the conclusions presented in this report are based 
solely on the study findings. We are, of course, responsible 
for these conclusions. 

We would like to offer two cautions to readers of this report. 
First, the PEIs were deliberately constructed to provoke debate 
on issues which are heavily value-laden. This fact is reflected 
in the diversity of opinions expressed by panelists, and described 
in this report. Readers of this report, like panelists, may 
sometimes find themselves caught up in the debate, agreeing with 
one perspective or disagreeing with another. While we trust 
that this sense of participation will enliven the report, we 
also trust that readers will remember that the report describes 
the diversity of opinions expressed by panelists, and not posi- 
tions or views advocated or subscribed to by study staff. 

The second caution relates to the generalizability of cer- 
tain results. It is possible to generalize \jith some confidence 
the results of the national opinion survey what Americans think 
about a particular issue, since the survey respondents represented 
a probability sample of the non-institutionalized adult popula- 
tion of the continental United States. However, much greater 
caution should be exercised in generalizing from the responses 
of categories of panelists, such as social scientists, how 
all members of that category would respond to a particular 
issue. Panelists were selected for their expertise and inter- 
est in the study subject, and each panelist categorized 


him/herself as either an ethicist, lawyer, medical scientist. 


Ac knowledge- 
ments 


Study 

Products 


representative of the public interest, or social scientist. 

The only purpose of comparing the responses of panelists in one 
category with those in another was to explore fundamental dif- 
ferences of opinion within the panel itself. 

We would like to thank everyone who particpated in this study: 
our colleagues on the Study Design and Management Group; its 
consultants, the other consultants to the study, the study 
coordinating staff; the study administrative staff; the 121 con- 
sultant panelists, particularly those who undertook additional 
assignments; the 1679 Americans who consented to be interviewed 
in the national opinion survey, the staff of Louis Harris and 
Associates, Inc. who administered the survey questionnaire and 
the staff of Hollander, Cohen Associates, Inc. who pretested it; 
and the staff of the Commission and the Commissioners themselves. 

The following members of the study team deserve special 
mention. They are: Prakash Grover and John Williamson, who 

diligently reviewed all study instruments and reports; Bruce 
Sanders and Ken Dane, who assisted in drafting this report 
and the summaries of responses to the three PEIs; Kathy Crouch, 
Skip Locks, and Beverly Randall who typed the study instruments 
and reports; and Miriam Kelty, the Project Monitor, who provided 
assistance at every stage of the study. 

The following ten volumes of material pertinent to this study 
are available. 


Vlll 


Summary of the Final Report. This volume is a concise 
summary of the study purpose, methods, principal findings, and 
conclusions. (32 pages) 

The Final Report. This volume describes the need for the 
study, the study purpose, methods, findings, and conclusions. 
(298 pages) 

Policy Evaluation Instrument - 1. The first PEI sent to 
consultant panelists for completion. (206 pages) 

Summary of responses to the first Policy Evaluation 
Instrument. This volume summarizes: the implications of the 

15 advances examined (three in each of the five subject areas), 
and the appropriate policies to respond to them; the advances 
added by panelists; the implications underlying resolution of 
the six scenarios considered; the the policies that would be 
helpful in resolving issues of the type depicted. (402 pages) 

Policy Evaluation Instrument - 2. The second PEI sent 
to consultant panelists for completion. (250 pages) 

Summary of responses to ' the second Policy Evaluation 
Instrument. This volume summarizes: the negative consequences 

of implementing the research and implementation policy least 
liked by panelists with respect to five advances carried for- 
ward from the first PEI, and the ameliorative policies suggested 
if the least liked policy were implemented; panelists' elabora- 
tions of 23 general policy statements listed; and a summary of 
those urgent policies added by panelists. (272 pages) 

Policy Evaluation Instrument - 3. The third PEI sent to 
consultant panelists for completion. (288 pages) 

Summary of responses to the third Policy Evaluation 
Instrument. This volume summarizes: the positive and negative 

conseqeunces of implementing the possible national policy 
described in four policy scenarios, the barriers to implementa- 
tion and v T ays of overcoming them, and amendments offered to 
the particular policies that comprise the scenarios; appro- 
priate resource allocations to health, health R&D, and types of 
health R&D; and panelists' responses to the national opinion 
survey questions. (414 pages) 

Eatelira 1999. This volume provides alternative futures 
depicted in the form of newspaper stories written by panelists 
who responded to the third PEI. Panelists were asked to write 
two brief newspaper stories that might be filed by a science 
reporter in 1999: (1) if existing policies with respect to 

biomedical and behavioral research and technology continued to 
operate unchanged until that time; and (2) if the policies 
described in the third PEl's four policy scenarios were imple- 
mented in the late 1970s. (90 pages) 


ix 


National Opinion Survey. This volume contains the schedule 
of questions administered to a probability sample of 1,679 
Americans in individual face-to-face interviews — the national 
opinion survey. It also contains the report of survey results 
prepared especially in behalf of those respondents who requested 


a copy of the survey results. 

(18 pages) 

Peter G. Goldschmidt Irene Anne Jillson 

Principal Investigator President 

Policy Research Incorporated 
Baltimore, Maryland 

Sanford Bordraan 
Director 

Center for Technology Assessment 
New Jersey Institute of Technology 
Newark, New Jersey 






xi 


TABLE OF CONTENTS 


Preface i 

Chapter 1: Introduction , Summary 3 and Conclusions 1 

The Need for this Sp 'cial Study 3 

Study Mandate and Methods 5 

Findings of the Policy Study: Advances 11 

Findings of the Policy Study: Policies 19 

Findings of the National Opinion Survey 25 

Conclusions About Advances 30 

Conclusions About Policies 35 

Chapter 2: Advances 43 

Introduction 45 

Systematic Control of Behavior 50 

Reproductive Engineering 56 

Genetic Screening 62 

Extension of Life 68 

Data Banks, Computer Technology 74 

Figures on pages 82 to 89 

Chapter 3: Implications of Advances 91 

Introduction 93 

Implications for Individuals 94 

Implications for Society 102 

Moral and Ethical Issues 110 

Chapter 4: Policies 115 

Introduction 117 

Permanent National Commission 121 

Public Involvement in Policy Decision-Making 125 

Biomedical and Behavioral Research 129 

Implementation of Biomedical and Behavioral 

Technologies 133 

Resource Allocation Policy 137 

Figures on pages 140 to 148 

Chapter 5: Imp lamentation of Policies 149 

Introduction 151 

The Need for Controls 154 

The Role of Government 156 

Economic Factors 159 

Justice 161 

Public Participation 163 


Xll 


Chapter 6: Pu.blic Understanding and Attitude 165 

Introduction 167 

Advances and their Effects 168 

Application of Selected Advances 174 

Rules About Research, Safety and Efficacy of 

Tests on Treatments, Financial Responsibility 

for Treatment 180 

Research Priorities 183 

Value Received for Dollars Spent; Future Outlook .. 186 

Figures on pages 1S8 to 208 

Appendix 1; Methods 209 

Introduction 211 

Study Management 213 

Introduction to the Policy Study 215 

Selection of the Consultant Panel 218 

Selection of Issues 221 

The First Policy Evaluation Instrument 223 

The Second Policy Evaluation Instrument 227 

The Third Policy Evaluation Instrument 231 

Analysis and Summarization of PEI Data 236 

Introduction to the National Opinion Survey 238 

Design of the Survey Questionnaire 239 

Administration of the Questionnaire and Tabulation 

of Results 241 

Review of the Literature 245 

Preparation of the Final Report 247 

Figures on page 248 

Appendix 2: Members of the Study Design and Management 

Croup j Consultants to the SDMG 3 Study 
Coordinating Staffs and Study Administra- 
tive Staff 249 

Appendix 3: Consultants to the Study 253 

Appendix 4: Members of the Consultant Panel 257 

Appendix 5: Descriptions of the Fifteen Advances and 

Six Scenarios included in the First 
Policy Evaluation Instrument 265 

Advances in Systematic Control of Behavior 267 

Advances in Reproductive Engineering 269 

Advances in Genetic Screening 271 

Advances in Extension of Life 273 

Advances in Data Banks, Computer Technology 275 

Scenarios 27 7 


Xlll 


Appendix 6: Descriptions of the Four Policy Scenarios 

included in the Third Policy Evaluation 
Instrument 281 

Policy Scenario No. 1: Permanent National Com- 
mission 283 

Policy Scenario No. 2: Public Involvement in 

Policy Decision-Making 288 

Policy Scenario No. 3: Biomedical and Behavioral 

Research 290 

Policy Scenario No. 4: Implementation of Biomedi- 
cal and Behavioral Technologies 294 

List of Figures 

Figure 1: Most Important Advance in Each Subject 

Area by Panelist, First PEI 82 

Figure 2: Significant Implications of Advances 

by Subject Area, First PEI 83 

Figure 3: Policy Approach for Each Advance by 

Subject Area, First PEI 84 

Figure 4: Scenario Option Selected by Category 

of Panelist, First PEI 85 

Figure 5: Significant Implications of Scenarios, 

by Option Chosen, First PEI 86 

Figure 6: Policy Option Panelists Would Least Like 

to See Implemented for the Five Advances 
Considered in the Second PEI, by 

Subject and Category of Panelist 87 

Figure 7: Negative Consequences of Advances 

Considered in the Second PEI, by Least 

Liked Policy Option 88 

Figure 8: Groups Particularly Affected by the 

Negative Consequences of Adopting the 
Least Liked Policy Option, Promotion 
or Limitation or Control of Advances 

Considered in the Second PEI 89 

Figure 9: A Synopsis of the Four Policy Scenarios 140 

Figure 10: Degree of Support (or Opposition) for 
Implementing the Possible National 
Policy Described in the Four Policy 
Scenarios Described in the Third PEI, 

by Category of Panelist 141 

Figure 11: Panelists' Votes of the Particular 

Policies that Comprised Policy Scenario 
No. 1, Permanent National Commission, 

Third PEI 142 

Figure 12: Panelists' Votes of the Particular 

Policies that Comprised Policy Scenario 
No. 2, Public Involvement in Policy 
Decision-Making, Third PEI 143 


xiv 


Figure 13: Panelists’ Votes of the Particular 

Policies that Comprised Policy Scenario 
No. 3, Biomedical and Behavioral 

Research, Third PEI 144 

Figure 14: Panelists’ Votes of the Particular 

Policies that Comprised Policy Scenario 
No. 4, Implementation of Biomedical 
and Behavioral Technologies, Third PEI . 145 

Figure 15: Trends in Health Resource Allocation ... 146 

Figure 16: Median Panelists’ Resource Allocations, 

1980 and 1985, Third PEI 147 

Figure 17: Median Proportion of Funds that Should 
be Allocated to Each Type of Medical 
Research in 1975, According to Panelists 148 
Figure 18: New Tests, Treatments, or New Knowledge 
Made Possible in the Last 20 Years 

Mentioned by the General Public 188 

Figure 19: Access to New Tests and Treatments 189 

Figure 20: New Test or Treatment or New Knowledge 
Made Possible in the Last 20 Years that 
had the Greatest Good Effect on Society, 

and Their Effects 190 

Figure 21: Effect Mentioned for Each Class of New 
Test, Treatment, or Knowledge that had 
the Greatest Good Effect on Society in 

the Last 20 Years 191 

Figure 22: New Tests, Treatments, or New Knowledge 
Made Possible in the Last 20 Years That 
has had the Worst Effect on Society, 

and Their Effects 192 

Figure 23: Effects Mentioned for Each Class of New 
Test, Treatment, or Knowledge that had 
the Worst Effect on Society in the Last 

20 Years 193 

Figure 24: New Things Consultant Panelists and the 
General Public Wanted Medical Science 
to Come Up With in the Next 20 Years ... 194 

Figure 25: New Thing That Will Have Greatest Good 

Effect on Society, in the Next 20 Years, 

and Their Effects 195 

Figure 26: Effects Mentioned for Each Class of New 
Test, Treatment, or Knowledge That Will 
Have the Greatest Good Effect on Society 

in the Next 20 Years 196 

Figure 27: New Thing That Will Have Worst Effect cn 
Society in Next 20 Years, and Their 

Effects 197 

Figure 28: Effects Mentioned for Each Glass of Mew 
Test, Treatment, or Knowledge That Will 
Have the Worst Effect on Society in the 
Next 20 Years . 198 


XV 


Figure 29: Tests for Violent Acts: Use of Drugs 

to Prevent Violent Acts 199 

Figure 30: Tests for Certain Defects 200 

Figure 31: Select-A-Boy, Select-A-Girl Marketable 

Kits 201 

Figure 32: Most Important Effect that Ability to 

Select the Sex of Children Would Have on 
Society, According to View of Effect ... 202 

Figure 33: Appropriate Distribution of Select-A-Boy , 
Select-A-Girl Kits, by Effect of the Kits 

on Society 202 

Figure 34: Life and Death Decisions 203 

Figure 35: Rules About Research, Application of 

Technologies 204 

Figure 36: Financial Responsibility for Treatment . 205 

Figure 37: Research Priorities 206 

Figure 38: Decision-Making with Respect to 

Research 207 

Figure 39: Value Received for Dollars Spent; 

Future Outlook 208 



1 


Chapter 1: 

Introduction, Summary, and 
Conclusions. 






3 


THE NEED FOR THIS SPECIAL STUDY 

The gap between science fiction and science fact has narrowed 
steadily during the past several decades. It is, or soon will 
be within our power to transplant vital organs safely and rou- 
tinely; to use computers to monitor and control organs or 
organ replacements; to detect defective fetuses in the womb; to 
select the sex of our children; and to control the behavior of 
vast portions of the population by means of drugs. 

These are only a few of the more visible advances in the 
biomedical and behavioral fields. All of these advances, both 
existing and dreamed of, have been featured in the popular 
media in the past decade, and all have been brought into the 
realm of possibility by accelerated progress in technology over 
the past twenty years. 

Progress in Our present medical technology, of course, is a product of a 

Medical 

Technology century or more of steady progress in disease control. Technolo- 

gy available to physicians increased considerably after Koch 
first demonstrated unequivocally that specific organisms cause 
certain diseases (1876); after Erhlich made chemotherapy a prac- 
tical proposition (1909); after Fleming discovered penicillin 
(1928); and after penicillin and other antibiotics were made 
available in general medical practice just over 25 years ago. 

These scientific developments were achieved against infec- 
tious diseases, those caused by specific organisms. Not all of 
these organisms have yielded, however. Influenza and other 
varieties of viruses sweep the nation each winter. The common 


Effects of 

Medical 

Technology 


4 

cold remains something of a medical mystery, despite astonishing 
advances against other, apparently more complex diseases. And, 
our progress in preventing, treating or managing the diseases 
that have emerged as the leading causes of death — heart disease 
and cancer — has not been spectacular. Increasingly, we have 
recognized that many diseases are related to environmental fac- 
tors, social patterns, lifestyle, and personal habits. 

Advances in the biomedical and behavioral sciences can, and 
often do, have effects other than those related to health. They 

can alter our concepts about ourselves, our values, and the ways 

we behave. Many of them, the "pill", for example, have had as 
much impact on society as they .have had on individual health. 
Others have raised sharp questions of ethics and morals: what 

is fair and what is not; who shall live and who shall die; and 

what segments of our society can afford or have access to life- 

saving technologies. New medical technologies, in general, have 
sharpened the issues of how health care ought to be provided and 
how new technologies should be distributed. Crucial questions 
are posed; questions that, while not always totally answerable, 
at least require urgent attention by government, the law, the 
medical industry, and medical and behavioral scientists them- 


selves . 


5 


STUDY MANDATE AND METHODS 

Legislative In 1974, the U.S. Congress enacted the National Research Act, 

Mandate for 

the Study PL 93-348. Part of this act established the National Commission 

for the Protection of Human Subjects of Biomedical and Behavioral 
Research (the Commission). Section 203 of the Act mandated the 
special study which is the subject of this report. Section 203 
of PL 93-348 states "such Study shall include — 

(1) an analysis and evaluation of scientific and 
technological advances in past, present, and 
projected biomedical and behavioral research 
and services; 

(2) an analysis and evaluation of the implications 
of such advances, both for individuals and for 
society; 

(3) an analysis and evaluation of laws and moral 
and ethical principles governing the use of 
technology in medical practice; 

(4) an analysis and evaluation of public under- 
standing of and attitudes toward such implica- 
tions and laws and principles; and 

(5) an analysis and evaluation of implications for 
public policy of such findings as are made by 
the Commission with respect to advances in bio- 
medical and behavioral research and technology. 

In addition, the Request for Proposals to undertake the 
study noted that one should be particularly cognizant of the 
"implications of biomedical and behavioral scientific and tech- 
nological advances for ethnic, racial, and economic minorities." 

Policy Research Incorporated and the Center for Technology 
Assessment of the New Jersey Institute of Technology were 
awarded a contract to conduct the special study. The special 
study consisted of two components, designed to respond to the 
mandate. They were: a policy study involving a national panel 


6 


Policy 

Study 


Selection 
of the 
Panel 


of 121 experts in the subject of the study; and a national 
opinion survey, an adjunct to the policy study suggested by the 
study's designers as necessary to meet the Congressional man- 
date. The study was designed and managed by an eight member 
Study Design and Management Group. The study began in September, 
19 75 and was completed in January, 1977. 

The policy study used a dynamic communications technique speci- 
fically designed to analyse complex, value-laden, policy related 
subjects. It was a structured, iterative inquiry carried out 
through the medium of three Policy Evaluation Instruments (PEIs) 
mailed to and completed independently by 121 members of a con- 
sultant panel between February and August, 1976. Each PI! after 
the first was developed on the basis of previous responses, and 
was accompanied by material summarizing response.3 from the pre- 
ceding instrument, establishing a dynamic process in which panel- 
ists were able to compare and contrast their own views with 
those of; others. 

In order to insure the representation of a variety of views, 
the panel was drawn from the following five broad categ 


* ethicists, philosophers, and religio- 1 

* lawyers and members of the judiciary; 

* medical scientists and persons in related field..; 

* representatives of the public interest, elected and 
appointed officials and members of special Interest 
groups ; and 

* social scientists. 

Nominations to the panel were obtained from project SCm ff 


and consultants, the staff of the Commie-. i on, «' it; , 





7 


Selection of 
Subject Areas 
and Advances 


ranking minority members of seven Congressional Committees and 
Subcommittees relevant to the subject of the study, and from 
panelists themselves. Biographical information was gathered 
for all nominated persons and reviewed independently by four 
project staff members. Final selection of panelists was made 
in a number of discrete waves from the pool of nominees felt 
to be appropriately qualified by reviewers. Qualified persons 
were selected so as to insure representation on the part of 
minorities and women and so that panelists were drawn from all 
regions of the country. The final Consultant Panel represents 
the 121 panelists who completed one or more of the three Policy 
Evaluation Instruments. 

Five representative areas of technology were chosen for exami- 
nation in the policy study. These areas were selected from 
larger lists produced by ten members of the Consultant Panel 
(two from each panelist category) at an Issues Clarification 
Meeting held shortly after the inception of the study. Selec- 
tion of the issues was based on the expection that major ad- 
vances in these areas would take place within 20 years, and 
that such advances would collectively generate a broad range 
of ethical, legal, and social concerns. The five subject areas 
selected for examination in the study were? 

* Systematic Control of Behavior; 

* Reproductive Engineering; 

* Genetic Screening; 

* Extension of Life; and 

* Data Banks, Computer Technology . 


8 


Anticipated future advances in these subject areas were pro- 
vided by expert consultants in each of the five areas. Three 
advances were selected for inclusion in each subject area, and 
six scenarios which treated advances as pragmatic problems were 
also included in the study. 

Development In the first Policy Evaluation Instrument, panelists identified 

of Findings 

the most significant advance in each subject area, analyzed and 
evaluated -the implications of this advance, and suggested poli- 
cies which might be adopted with respect to the advance. In 
the second PEI, panelists examined the consequences of implement- 
ing specific policies with respect to the promotion, or control 
or limitation of five selected advances, brought forward from 
the first PEI. In addition, panelists voua on a series of 
general policy statements to deal with advances, and elaborated 
on the three policies they considered most urgent to implement. 

In the third PEI, panelists were asked to examine the impli- 
cations of implementing a comprehensive national policy to con- 
trol and regulate biomedical and behavioral research and tech- 
nology; identify the barriers to implementing the policy and 
ways to overcome these barriers; add any additional elements 
to the policy they felt necessary; and provide any amendments 
to the policy they considered warranted. The national policy 
was based on panelists elaborations of the policies selected 
as most urgent to implement, and was cast in the form of four 
policy scenarios which specified: (1) the establishment of a 

new independent agency (entitled the Remanent National Corr 'c,- 
sion on Biormdical and Behavioral Research and Techno I oljv ) ; 


9 


Intrepretation 
of Findings 


National 

Opinion 

Survey 


(2) public involvement in policy decision-making; (3) review 
authority and procedures for biomedical and behavioral research; 
and (4) implementation of biomedical and behavioral technology. 
Panelists also reviewed and allocated national expenditures for 
biomedical and behavioral research, and wrote newspaper articles 
on the status of bioscience at the turn of the century. 

Structured responses to PEIs were analyzed statistically. Open- 
ended items were summarized by study staff, and these summaries, 
together with copies of the verbatim transcripts of responses, 
were provided to panelist reviewers who analyzed them to identify 
the dimensions underlying the responses and to insure the accur- 
acy and completeness of the summaries. Another panelist inde- 
pendently reviewed a set of summaries to identify the dimensions 
common to all the items summarized, those that cut across several, 
and those unique to a particular item. The dimensions were 
analyzed by study staff to identify common themes. 

The national opinion survey was designed to elicit public senti- 
ment towards advances in biomedical and behavioral research and 
technology, and opinions about appropriate policies to handle 
them. The survey questions were derived in part from the first 
two Policy Evaluation Instruments completed by panelists. 

The questionnaire was administered to a random sample of 
the non-institutionalized adult population of the continental 
U.S. A total of 1,679 completed interviews were obtained in the 
fall of 1976. In order to provide a basis for evaluating public 
understanding and attitude, a parallel version of the quesion- 


10 


naire was included in the third PEI sent to consultant panelists. 
Survey responses were analyzed statistically and the responses of 
the public and the panel were compared and contrasted. 

The remainder of this chapter of the report presents brief 
summaries of the major findings of the policy study and the 
national opinion survey, and the conclusions of the special 
study. 


11 


FINDINGS OF THE POLICY STUDY: ADVANCES 

The implications of advances are summarized below by subject 
area, followed by the implications of advances for individuals 
and society, and for moral and ethical issues. 

Systematic Panelists were divided over whether advances in Systematic Con- 

Control of 

Behavior trot of Behavior would enhance or detract from individual free- 

dom. There was particular apprehension about the possibility 
of government intervention going too far, and though benefits 
were discussed such as increased productivity, lowered cost of 
curbing social deviance, and profits for private enterprise, 
these were balanced against the cost of compromising individual 
rights and the notion that behavioral treatments might become 
the only acceptable option for controlling social problems. 

The advent of drug therapy for mental illness brought great 
benefits to sufferers who could lead lives more closely approach- 

-V 

* 

ing the "normal"; it also may have changed our concepts of mental 
health and mental illness. Drug therapy for mental illness may 
have established a climate for acceptance of drugs not only to 
relieve physical, mental, and emotional pain but also to produce 
pleasure. Some panelists viewed these developments positively, 
while others were negative, feeling they would result in an 
unusual or unhealthy reliance on drugs, or in the subversion of 
values. Moreover, drug therapy was seen to pose dilemmas for 
individual freedom versus societal benefits, as do all types 
of behavior control. Someone (or some group) must eventually 
decide whose behavior will be controlled and to what extent 
the mentally ill have rights to accept or refuse drug therapy. 


12 


Reproductive 

Engineering 


Genetic 

Screening 


Reproductive Engineering, which included the imminent commer 
cial availability of "Select-a-bog 3 Select-a-girl" kvts, has 
implications stemming from predicted changes in the sex ratio 
in society, extending even to the stability of society and to 
the form and content of marriage and the family. Panelists sa 
such advances in Reproductive Engineering as challenging these 
basic patterns. Tension between individual rights and freedoms 
and the "good of society" was pervasive in panelists' examination 
of these technologies. 

Some panelists felt that individuals had the right to use 
reproductive technologies. People could be free to choose 
whether or not to have children, to determine family size or 
composition, and to sever the link between sexuality and repro- 
duction. However, others felt that the absolute exercise of 
such rights as the ability to select the sex of one’s children 
must be restrained to avoid social disruption manifested in 
predictions of changes in the sex ratio — or to family con- 
flicts where the views of one individual clashed with another. 

Equity was also at issue. Some panelists feared that re- 
stricted access to scarce and expensive technologies (such as 
in vitro fertilization) would discriminate against the poor. 
Others feared that the availability of inexpensive technologies 
(such as medical sterilization) might result in their differ- 
ential promotion to selected groups such as the poor or 
minorities . 

The principal concerns in Genetic Screening were the trade-offs 
between individual rights and the public good and, to a lesser 


13 


extent, resolution of problems of long-term genetic change and 
equity in distributing the technology. 

Some panelists thought that individuals had "rights" to 
the kind of information provided by screening programs, and 
associated these rights with the exercise of personal respon- 
sibility for decision-making. Contrasting with this view, other 
panelists suggested there should be a right not to seek the 
information which would be provided by a screening program, and 
that this personal choice could be perverted or denied by gov- 
ernmental or coraraerical coercion or through social pressures. 

The relationship between screening technologies and abor- 
tion as a resulting therapeutic intervention lies at the base 
of many concerns about the social aspects of screening. Abor- 
tion of defective fetuses was viewed favorably by some panelists 
in that it could decrease the cost of custodial care or treat- 
ment. Some argued that it was imperative to avoid these costs, 
which were generally seen as rebounding onto society when they 
exceeded a family's ability to sustain them. Other panelists 
were concerned that the identification of defectives could only 
bolster a growing notion that abortion is a responsible and 
acceptable course of action, which would intensify pressures on 
those morally or religiously opposed to it. These panelists 
argued society should support options which would allow those 
not in favor of abortion to avoid it without social stigaa. 

Concern was also apparent for the existing population of 
"defectives" and for those who might "slip through the net" of 
screening technologies. Some panelists feared that the fewer 


14 


defectives, the greater the stigma for those who remained. 
Finally, there was substantial agreement that implementation of 
screening programs would require equity in the distribution of 
the technology in order to prevent the development of a differ- 
ential birth rate of children with defects among particular 
ethnic or economic minorities. 

Extension Panelists saw issues related to Extension of Life more as trade- 

of Life 

offs than as pros and cons. The question was not whether there 
were costs on one side and no costs on the other, but rather 
which costs should be borne by whom. 

Extending life presents problems with respect to the allo- 
cation of redistribution of scarce resources. For example, in- 
vestment in these technologies may force the taxing of the many 
for the support of those few maintained by expensive life-sus- 
taining equipment. Panelists showed little interest in providing 
extensive funding for developing these technologies (though they 
are currently the object of considerable popular attention). 

Life extending technologies will increase the proportion of 
older people in the population, raising a potential resource 
allocation conflict between generations. Advances in life 
extending technologies may also cause us to choose between sup- 
port for medical intervention and for prevention. 

While the prevention of disease and trauma may lead to 
improved and longer life, it has many other implications besides. 
For example, panelists noted tension between the individual's 
seeking governmental protection in areas beyond his power t. 
control, while at the same time fearing the loss of individual 


15 


Data Banks, 

Computer 

Technology 


freedom. Thus, in the minds of many, the government should 
chastise polluting industries but it should emphasize education 
rather than prohibitive laws on products when it comes to smoking 
or other aspects of personal lifestyles that affect health. 

The major implications of Data Banks , Computer Technology re- 
lated to invasion of privacy. Even proponents of the technolo- 
gies admitted the potential for invasion of privacy and for nega- 
tive effects on the poor and minorities, many of whom would be 
unwilling or unable to use the technology. While proponents 
of computer technology felt the potential benefits outweighed 
the risk of a slight loss of personal autonomy opponents feared 
that even the willingness to accept such a trade-off would erode 
present values for privacy and confidentiality. 

Positive and negative effects were also seen for the quali- 
ty of health care. Claims by proponents included predictions of 
reduction in the cost of care, increased accuracy, speed and 
etse of access to medical records, and improvements in the quali- 
ty control of health care. Opponents countered these claims 
with predictions of higher costs for computer equipment and sup- 
port, loss of intimacy and trust in the physician-patient rela- 
tionship, and actual harm perpetrated through errors in pro- 
gramming or input. Similar arguments took place over benefits 
to research and planning as some felt computer technology would 
lead to great strides in research and planning while others con- 
sidered these claims at least overblown, if not unfounded. 


16 


Implications 

for 

Individuals 


Implications for individuals and individual rights were noted 
throughout all subject areas and advances, with both positive 
and negative effects identified. The panel generally upheld 
individual rights and values where these conflicted with the 
needs of society. The central question about individual rights 
related to whether or not they were freely relinquished. The 
panel generally objected to aspects of advances or policies which 
tended to curtail individual rights when individual consent 
was not solicited or received. 

Aspects of advances which tended to enhance individual 
choice and the exercise of personal responsibility were generally 
favored by panelists, though not to the same degree. Some panel- 
ists were unequivocally in favor of the absolute operation of 
concepts of individual freedom and autonomy while others viewed 
this as operating within a social context. While advances them- 
selves tended to be seen as increasing individual choice and 
responsibility, the interaction of technology was the individual, 
society, the government, and various agencies was sometimes seen 
as limiting choice. 

Questions of individual health centered largely on the 
relative risks and benefits of research and technology. Where 
the potential existed for technologies to result in physical 
harm, or where there was a possibility that inequities in the 
distribution of the technology would differentially affect in- 
dividuals of differing backgrounds or classes, panelists divided 


over whether the risk of harm or inequity was acceptable. 


17 


Implications 

for 

Society 


Comments on social concerns and issues were frequent, often 
complex, and indicative of conflict. Social issues were fre- 
quently arrayed against individual or ethical issues where social 
benefits or harms were seen as being traded-off against ethical 
or individual benefits or harms. 

Technological effects such as new knowledge and improvements 
in health care were often mentioned as social benefits, and a 
number of panelists appeared to hold the implicit assumption 
that a f reewheeling approach to technological development would 
produce the greatest good for the greatest number. This view- 
point was challenged by others who felt that all out promotion 
of technology was likely to prove harmful in the long run. 
Similarly, economic issues produced disagreement over whether 
the added costs of bureaucratic supervision, believed necessary 
to control some technologies, would overwhelm the economic 
benefits which they might produce. More global economic issues 
were also addressed, with some panelists noting that advances 
could lead to major changes in the national or world economic 
picture — such as the amelioration of the world population prob- 
lem, and redistribution of population away from areas of pollu- 
tion or polluting industries. 

Some technologies were seen as promoting changes in social 
patterns. In particular, some panelists considered developments 
in Reproducti ve Engineering as capable of producing changes in 
the sex ratio of the population, patterns of marriage and family 
life; behavior control technologies could influence the relation- 
ship between governing and governed; screening technologies could 
lead to notions of genetic equality as an obtainable social end. 


18 


Moral 

and Ethical 
Issues 


Finally, some panelists suggested that minorities and the disad- 
vantaged would suffer from the implementation of technologies, 
while others suggested that minorities and the disadvantaged 
would suffer from the failure to implement them. 

The broad moral and ethical issues identified by the study re- 
lated to potential changes in 'human biology and behavior and 
to the question of equity or social justice. Advances in Repro- 
ductive Engineering and Genetic Screening raised questions about 
the potential for changing the biology of the human species, but 
produced substantial disagreement over whether changes would 
actually occur. Developments in the Systematic Control of Be- 
havior might result in certain fundamental Western values of 
free will and personal responsibility being altered. Panelists 
tended to accept behavior control technologies if their use were 
confined to the rehabilitation of individuals, but decry their 
application to classes of people, or their use to avoid the 


exercise of personal responsibility. 


FINDING OF THE POLICY STUDY: POLICIES 


A Permanent 

National 

Commission 


The implications of policies are summarized below in terms of 
four policy scenarios that collectively described a comprehensive 
national policy for the control and regulation of biomedical and 
behavioral research and technology. Findings about resource 
allocation policy are also summarized briefly. Finally, the 
implications of a comprehensive national policy are discussed in 
terns of: the need for controls, the role of government, justice, 

economic factors, and public participation. 

The first policy scenario described a national agency (termed 
the Permanent National Commission on Biomedical and Behavioral 
Research and Technology ) and specified its scope, authority, 
accountability, membership, staffing, and evaluation. A majori- 
ty of panelists supported the concept of such a Commission. 
Panelists particularly approved of those aspects of the policy 
scenario involving dissemination of information produced by or 
about such a Commission. The most frequently offered amendments 
to the policy related to the Commission r s scope and level of 
authority . 

Discussions of the policy scenario revealed three major 
areas of disagreement about the Commission. Economic concerns 
formed one theme. Some panelists contended that present costs 
of research and care justified the establishment of a Commission 3 
while others contended the Commission itself would create stag- 
gering bureaucratic costs. A second theme was the quality of 
research where some contended that a permanent regulatory agency 
would create efficiency and enhance quality, while others con- 


20 


Public 

Involvement 


Biomedical 

and 

Behavioral 

Research 


tended that red tape and politicization of research would cause 
a deterioration in research quality. Finally, some panelists 
contended that present abuses of power in the health industry 
justified creation of an independent regulatory agency; others 
suggested the agency itself would become abusive in its use of 
power . 

The second policy scenario dealt with Public Involvement in 
Policy Decision-making and contained policies addressing public 
participation, the gathering of public opinion, dissemination 
of information, and provisions for the creation of five regional 
information centers. The panel split nearly equally in support 
of and opposition to this scenario. Many approved the ends of 
public participation; the means were less well liked. 

The panelists’ discussion of the policy scenario high- 
lighted major areas of disagreement. Panelists debated three 
views of the public — as interested, informed and helpful; as 
disinterested and likely to be led by demagogues; and as self- 
selected individuals and groups whose impact could be either 
positive or negative. The information centers specified in the 
policy were opposed by many panelists who feared they would be 
costly and not conducive to the improvement of research. Support- 
ers of these centers argued that they would supply more detailed 
and accurate information and increase public confidence in re- 
search. 

The third policy scenario outlined the scope of authority and 
control over Biomedical and Behavioral Research. Specific poli- 


21 


Biomedical 

and 

Behavioral 

Technologies 


cies covered the review of research proposals and projects, the 
es tablishment of review boards, and appeal and evaluation proce- 
dures. Nearly two-thirds of all panelists supported this policy 
scenario with the strongest support going for evaluating the 
risks and benefits of research, enforcement of guidelines and 
regulations, and the setting of policy with respect to the con- 
duct of research and the protection of human subjects. Two 
major themes emerged from the discussion of the scenario. One 
issue was that of the freedom of research and inquiry — main- 
tained by some as inviolable, but considered by others necessar- 
ily secondary to the public need. The other issue was that of 
the quality of research. Some panelists felt that rationaliza- 
tion of the review process and the development of standards for 
the conduct of research would improve research quality. Others 
contended the review process would be encumbered by bureaucratic 
inefficiency and would result in a decline in the quality of 
research . 

The fourth policy scenario addressed the Implementation of 
Biomedical ocnd Behavioral Technologies and specific policies re- 
lated to assessment and evaluation of technologies, promulgation 
of policies regarding use of technologies, and enforcement of 
guidelines and regulations. A narrow majority of panelists sup- 
ported this policy scenario. Opposition to the policy centered 
around the scope of control. Ilajor areas of support for the 
policy were in provisions relating to monitoring, evaluating, 
and assessing technologies. 

A principal focus in the discussion of the scenario was 


22 


Resource 

Allocation 

Policy 


Need for 
Controls 


health status. Many felt the policies described would improve 
the health of individuals and society. However, others were 
concerned that the policies would result in a limitation of 
choice of treatment options, contributing to a lowering of the 
health status of the population. Panelists also foresaw dif- 
fering impacts of the policy on the marketplace with some sug- 
gesting benefits in the reduction of dangerous or useless pro- 
ducts while others feared that the review and evaluations would 
be so expensive and time-consuming that only large companies 
could provide the capital for development, thus driving indivi- 
dual or small-group development efforts from the field and 
abetting the growth of monopolies. 

The majority of panelists favored future resource allocations 
which would : increase the percentages of the nation's alloca- 

tion of Gross National Product to health; increase the percen- 
tage of the health dollar that goes to health research and 
development; generally increase total Federal outlays to re- 
search and development; and increase the percentage of Federal 
research and development dollars going to health. Panelists 
were unanimous in favoring greater allocations to biomedical 
research than to behavioral research. There was also general 
agreement that a greater proportion of resources should be 
allocated to health services and quality assurance research md 
a lesser proportion to basic research than at present. 

Panelists were split over the need for the control of biomedical 
and behavioral research and technology. Some panelists were 




23 


strongly in support of a comprehensive national policy which 
would control and regulate all research and implementation, pub- 
lic or private, at all stages. These panelists tended to see 
the present system as uncontrolled and indifferent to social 
need. Opposing this view were panelists who favored continua- 
tion of a loosely knit system of control, supplemented where 
necessary by the strenghening of existing agencies, or the use 
of aci hoc measures. These panelists tended to consider peer 
controls sufficient to guide research. 

Role of Those in favor of regulation tended to see the role of govern- 

Governnent 

ment as beneficial, providing coordinating, planning, and repre- 
sentation. Panelists opposed to the regulatory approach were 
certain that the attendant bureaucracy itself would be restric- 
tive, unresponsive, and inefficient. Additionally, they feared 
that research quality would suffer as the bureaucracy favored 
those who could manipulate red tape over those who were truly 
creative. 


Economic Panelists favoring a comprehensive national policy for research 

Factors 

hoped for economies to result from the coordination of research 
and the delivery of health care. They suggested that duplica- 
tion would be avoided, available funds would be equitably dis- 
tributed, and insurance premiums or malpractice awards might be 
reduced. Countering these favorable views was the fear that a 
massive regulatory bureaucracy would drive the costs of research 
and health care delivery even higher. In addition to costs in 
Federal dollars, some feared that regulation would create higher 


24 


Justice 


Public 

Partici 


prices to consumers as providers of goods and services passed 
on the regulatory overhead. 

There was considerable agreement among panelists regarding the 
desirability of such things as equality of opportunity, the 
provision of safeguards for special groups, and the need to com- 
pensate subjects of research for any harm. The major differences 
which appeared in this area related to questions of the freedom 
of individual researchers or the research community to pursue 
their own course. Some panelists felt that a comprehensive 
regulatory policy would violate the individual rights of research- 
ers; others saw the curtailment of individual rights as a legi- 
timate subordination of the individual to society, rather than 
as an infringement on personal liberty. 

The active involvement of the. public in the biomedical and ha- 
lation 

havioral research and development enterprise was lauded by some 
panelists who felt that research could be made more responsive 
to social need and that a dialogue between producing researcher 
and consuming public would prove beneficial to research and to 
society. The restoration of public confidence in research, de- 
creased polarization on important issues, and an anticipatory 
rather than reactive approach to technological development were 
seen as likely products of increased public participation by some 
panelists. These views were directly contradicted by others who 
felt public confidence in research would be undermined by the 
emphasis on rules and regulations, dogma would be substituted for 
dialogue in public debate, and the public would be lulled into a 
false sense of security — that "something was being done". 


25 


FINDINGS OF THE NATIONAL OPINION SURVEY 


Past and 
Future 
Advances 
and Their 
Effects 

The findings of the national opinion survey are summarized 
below, with the responses of the public compared and contrasted 
to those of the Consultant Panel. Findings are described under 
five headings: past and future advances and their effects; use 

of advances; financial responsibility for treatment; research 
priorities; and value received. 

Seventy-seven percent of Americans could name at least one new 
test, treatment, or item of new medical knowledge that has come 
about in the last twenty years. Neither the public (60%) nor 
the panel (91%) felt that all types of Americans can equally get 
the new tests and treatments made possible by medical research. 
Two-thirds of the public, and virtually all panelists, mentioned 
the poor and disadvantaged as Americans who did not have equal 
access to new tests and treatments even when they need them. 

The majority of the public (70%) and panelists (86%) thought that 
today people who can pay for a new test or treatment or who know 
an important doctor, were those most likely to get it when it 
first comes out, and there is limited availability. Most of the 
public (35%) and the panel (82%) thought that people who apply 
first for tests or treatments or those who need them most should 
get a new test or treatment. 

Both the panel and public were asked to assess the past as 
well as to predict future advances. A plurality of both panel- 
ists and public agreed that the Prevention of infectious diseases 
has had the greatest good effect on society over the past 20 


years. Hovrever , other past advances mentioned by the public 


26 


were not necessarily the favorites of panelists. Twenty-six 
percent of the public but only one percent of panelists mentioned 
Prevention, treatment of cancer, while panelists more often 
mentioned Improved contraception and "The pill". 

Only about half of the public who could think of a new 
test, treatment or item of knowledge could mention a specific 
item with a bad effect on society — and it was, most often. 
Improved contraception. More than three-quarters of panelists 
mentioned an advance with a bad effect — most often Treatment 
for mental illness, specifically Drug therapies and Proliferation 
of tranquilizers . In general, health effects predominated as 
the greatest good effects in the past, while social-ethical 
effects predominated as the greatest bad effects, in the. opinion 
of both public and panelists. 

Projecting the good and the bad in the future -- the next 
20 years — panelists and public again were divided, but again, 
health advances dominated the good predictions and ethical / indiv i- 
dual/political/social effects dominated the bad . The public saw 
Treatment for mental illness (specifically Proliferation of tran- 
quilizers) and Selection of sex of offspring as the advances most 
likely to produce bad effects, while panelists predicted Control 
of behavior. 

One of the points on which the public and panel agreed was 
that the most desirable advance in the next 20 years is F-?y no- 
tion, treatment of cancer. It was the top priority of 59/ of 
panelists and 73% of the polled population sample. Dr ive-. ’ 
treatment of heart disease, other than surgery (36/ and 26 ) 


27 


was the second priority, followed by Treatment for mental 'ill- 
ness (237, and 14%). 

Use of The panel and the public held Jittering opinions on research to 

Advances 

change behavior and to determine which people are likely to com- 
mit violent acts. Panelists were much less supportive than the 
public of such research and of the application of tests predic- 
tive of violent acts. For example, 71% of the public (46% of 
the panel) voted to have tests developed to spot those likely 
to commit violence. The universal administration of such a test 
by the government was agreed to by 41% of the public, even though 
it might be an invasion of privacy (19% of the panel agreed to 
the same proposition). Finally, a majoi Lty of the public (647.) 
thought that the government should make people who have already 
committed a violent act take a drug to prevent them from commit- 
ting further violence compared to 42% of the panel. 

There was more agreement between the panel and the public 
regarding tests for fetal defects. Over 90% of the panel and 
nearly three-quarters of the public thought that if she wanted 
it a pregnant woman should have a test to tell if her unborn baby 
had certain defects — even if the government had to pay for the 
test. A majority of both panel and public also said that if a 
defective fetus were identified a woman should have personal 
choice about whether or not to seek an abortion. However, 21% 
of the public (6% of the panel) said a woman should not have an 
abortion because it is wrong to destroy any life, while 23% of 
the public (31% of the panel) said it is wrong to bring children 


with serious defects into the world. 


28 


Financial 
Responsibility 
for Treatment 


Research 

Priorities 


Two-thirds of the public, and 60% of panelists said they would 
not use a self -administered Seleet-a-boy > Select-a-girZ kit to 
choose the sex of their child. Panelists and public agreed that 
families would more often select boys, particularly for the first 
child, and that if people could select the sex of their children 
tnis would have a bad effect on society. A majority of the panel 
and the public said that the result would be an imbalance in the 
sex ratio. However, a majority of both the pane], and the public 
were willing to allow marketing of the kits, although the public 
was less inclined than panelists to allow marketing of the kits 
without a prescription. 

The public and panel were also asked who should shoulder the 
cost of illnesses caused by environmental factors (such as pol- 
lution) and by personal habits (such as smoking). Both agreed 
that agencies or individuals should be responsible when they 
are at fault (as with diseases caused by pollution or personal 
habits) but that social, risk-sharing mechanisms (health insur- 
ance) should operate when the diseases are caused by an indivi- 
dual’s inherited make-up, or by bacteria or viruses. There 
was also substantial majority support from both panel and pub- 
lic for individuals* access to information about a doctor’s 
treatment record and to be able to take part in risky experiments, 
so long as the risks are known and understood beforehand. 

While the panel held clear views about research priorities, the 
public seemed ambivalent on most questions. Almost all panelists 
supported research toward healthy life to age 70, rather than 


29 


prolonging life past 70. The panel also overwhelmingly sup- 
ported basic health care rather than research into new tests 
and treatments, and research into the prevention rather than cure 
of illness. The public tended to vote in a manner similar to the 
panel, but frequently volunteered "both equally" as the preferred 
option. The only area of clear agreement among the research 
priorities was that panel and public were both overwhelmingly in 
favor of government support for research to help people take bet- 
ter care of themselves. 

Panelists felt the government should do most research on 
environmentally caused illness, next on illnesses caused by 
bacteria and viruses, next on inherited illnesses, and finally, 
illnesses caused by personal habits. The public agreed with the 
panel in ranking research into diseases caused by personal habits 
lowest, but the remaining three categories were too close to call. 

A majority of both panel and public agreed that researchers, 
scientists, and doctors should have the greatest say in deciding 
what problems medical researchers should work on. 

Value The panel and the public strongly agreed that we receive good 

Received 

value for medical research paid for by the government. There 
was also agreement that past advances had changed life for the 
better, and that future advances would do the same. Almost 90% 
of the public and the panel thought that they or their families 
had benefitted from medical research in the past twenty years, 
and over 90% felt that such research had significantly improved 
the life of the average person. 


30 


CONCLUSIONS ABOUT ADVANCES 

During the last century, we have made great strides in our under- 
standing of and ability to influenc our health and behavior; 
seemingly these advances are occurring at an ever increasing 
rate. The benefits to be derived from new knowledge and new 
technology to promote health, to prevent ill health, and to 
treat sickness when it does occur are apparent. No less impor- 
tant, but perhaps less obvious, are the flaws in our knowledge, 
and the unintended consequences of applying the technologies that 
result from research. 

We have become increasingly aware that new technologies can 
directly or indirectly affect present and future individuals in 
society in unsuspected and perhaps deleterious ways. The more 
technology we apply the more opportunities there are for unin- 
tended negative consequences to occur. Technology may also serve 
to raise new conflicts or sharpen old ones. 

This special study analyzed and evaluated the implications 
of advances in biomedical and behavioral research and technology 
and of policies to deal with research and the implementation of 
resultant technologies. Public understanding of and attitude 
toward these matters was also examined. The general conclu- 
sions to be drawn from the policy study and the national opinion 
survey that comprised the special study are presented below. 

Nature of The biomedical and behavioral advances that may most affect so- 

Future Advances 

and Their ciety in the next twenty years are extensions of those we know 

Implications 

today. Neither the expert consultants who provided information 
on possible advances which were used as the basis for the study 


31 


nor the Consultant Panel identified advances which departed signi- 
ficantly from technologies under development or in existence to- 
day. Nor are the foreseen implications of these advances strik- 
ingly different from those we have already experienced, although 
some conflicts will be sharpened and old problems brought to 
light in a new perspective. There was considerable disagreement 
among panelists on: the probability that a given effect would 

occur; the magnitude of that effect; its significance; and the 
desirability of its occurrence. In part this disagreement stems 
from assessments based on differential knowledge; in part from 
differences in worldview, or in values. Individual rights and 
societal need formed a central concern in this respect. 

Ends and When people are asked about desirable advances in biomedical and 

Means 

behavioral research, as the panel and the public were in the 
national opinion survey, they tend to think of things which have 
major health implications or effects, e.g., a cure for cancer. 

In addition, they seem to assume that the means by which these 
health benefits will be attained are themselves good, or at 
least do not conflict with other equally important values. How- 
ever, when advances are focused, and the means of their attain- 
ment delineated, as they were in the policy study, issues of 
value begin to arise. Careful analysis may show that the health 
benefits may not be as great as once imagined; there may even 
be the potential for iatrogenic impairment of health. More 
importantly, the means by which the health benefits are to be 
attained may come to be seen as harmful or dangerous either to 
people directly or to their rights. Examined at this level of 


32 


detail, advances may no longer look so attractive. For example, 
if the prevention or treatment of cancer (ranked first in the 
opinion survey as having the greatest good effect on society in 
the next txventy years) could only be accomplished through the 
rigid specification and control of individual behavior, it is 
doubtful if it would be regarded as the most desirable advance. 


Potential 
Effects of 
Advances 


Advances that might be expected to occur in the next 20 years 
have the potential to: 

* effectively prevent the transmission of a variety of 
genetic diseases; 

* contribute markedly to the solution of the world 
population growth problem; 

* contribute to the general improvement of individual 
health care for all members of society; 

* significantly decrease certain health care costs, 
particularly the costs of custodial care; 

* enhance research and development in epidemiology and 
preventive medicine; and 

* ameliorate the individually debilitating effects of 
anxiety and depression and the socially debilitating 
effects of criminal aggression. 

However, they also have the potential to: 

* substantially alter the present genetic make-up of 
American society, if not the world; 

* substantially alter the sex ratio of American society, 
if not all the world; 

* substantially alter present values regarding life and 
death, abortion, euthanasia, privacy, human rights, 
and individual responsibility; 

* substantially alter basic American social patterns 
of marriage and family life; 

* create entirely new "minority" or disadvantaged 
groups based on health status; and 


33 


Need to 

Mediate 

Conflicts 

Among 

Values 


* cause redistribution in the economy through prolonging 
the average life span. 

Thus, advances have the potential both to increase individual 
freedom and to limit it; to increase societal stability and to 
reduce it. What balance will be struck depends on one's assess- 
ment of the likelihood of an event occurring and the policies 
one institutes to alter these probabilities in what one consid- 
ers a desirable direction. For any given advance, some panelists 
believed that benefits outweighed harms; for others harms out- 
weighed benefits. 

Most of the concerns raised by panelists about advances 
in biomedical and behavioral research aid technology, and about 
policies to respond _o them, could be raised in many other areas 
of life. Yet concerns about justice and equity, individual 
rights and societal stability, and costs versus benefits seem 
particularly compelling when viewed juxtaposed with life and 
death, reproduction, and our genetic future. 

The need to mediate potential conflicts among values was apparent 
throughout the study. Some mediation will involve trade-offs 
between complementary values such as that between individual 
rights and societal needs. All of the subject areas raised 
questions about this particular trade-off, and it was very 
clearly illustrated in Systematic Control of Behavior . The 
application of technologies to control behavior — particularly 
violent behavior — appear extremely attractive to many, parti- 
cularly among the public in the national opinion survey. Yet 


the application of behavior control technologies raises questions 


34 


about individual rights. Who will decide what behaviors to 
control? Who will administer the controls? Who will watch 
the watchers? Will any resultant limitation of rights ultimately 
affect society more adversely than if the controls were not 
applied? 

Sometimes, apparently good ideas can have counterintuitive 
consequences that ultimately require trading-off one good with 
another. For example, providing information about physician 
performance may allow people to make more informed choices 
among practitioners — promoting individual freedom of choice. 
However, given practitioners of unequal skill, there is likely 
to be competition for the skills of highly rated physicians — 
thus creating potential problems in the equity of health care 
distribution. Are the highly prized to be highly priced? If 
not, how are their services to be distributed? 

Many of the implications of advances foreseen by panelists 
will pose considerable problems for society. Many issues will 
have to be resolved, many trade-offs examined, and many decisions 
made. Draconian measures are not necessary, and hasty, ill- 
conceived action may be counter-productive. At least for the 
present, * there is time to improve inadequate systems of control 
and to construct new ones where necessary. However, panelists 
did warn against inaction. They expressed a sense of urgency; 


action is required. 


35 


CONCLUSIONS ABOUT POLICIES 

Most, but not all, panelists rejected the present piecemeal 
approach to developing policy with regard to biomedical and 
behavioral research and technology. Also rejected by the 
majority of panelists was the notion that enhancing the mandate 
of existing agencies and institutions would suffice to deal 
with the problems that are likely to be faced in research and 
in the implementation of technologies. 


Creation 
of a New 
National 
Agency 


These panelists believed a new independent national agency was 
needed. Such an agency could: 

* formulate national policy, and facilitate coordination 
among the agencies that implement policy such as the 
National Institutes of Health, and the Food and Drug 
Administration; 

* monitor and evaluate agencies charged with implementing 
policy; 

* review and evaluate the implications of research and 
the implementation of technologies; and 

* inform the public and scientific community and 
facilitate public participation in policy decision- 
making. 

By fulfilling these functions, such an agency would: 

* defuse issues, mediate value conflicts, and anticipate 
problems ; 

* protect research subjects; 

* protect consumers from short- and long-term harms; and 

* improve resource allocation. 

Many panelists saw a central policy-making agency not sim- 
ply as a way of avoiding abuse, but also as a means of doing 
good. For the most part, however, it was recognized that the 
new national agency would not solve many problems — because 


36 


Relationships 
with Existing 
Agencies 


they cannot be solved. In the end, for every gain there is a 
loss, and the trade-offs must be made clear to all concerned. 
Moreover, the purpose of such an agency was not seen simply to 
prevent all risks to all people on all occasions, but to assess 
the risks and benefits, and strike the appropriate balance. 

While there was considerable disagreement among the pane- 
lists about the scope and power which ought to be accorded a 
national policy-making body, there Xv'ere some areas of general 
agreement. Agreement was widespread for policies which involved 
regulating the conduct of research, including the protection 
of human subjects and the assessment of risks and benefits of 
research to both individuals and society. Policies involving 
the enforcement of appropriate conduct of research and use of 
technologies, including penalties for abuse or misuse, wore also 
widely supported. 

In establishing a new national agency, cognizance would need 
to be taken of developing the appropriate linkages with such 
existing agencies as the National Institutes of Health, the 
Food and Drug Administration, the White House Office of Science 
and Technology Policy, and the Congressional Office of Technology 
Assessment, with a view toward strengthening liaison, pi 
duplication of effort (particularly with regard to regulatm <3, 
preventing interagency rivalry, and establishing, clear lines 
of authority and responsibility. Care should be taken to avoid 
simply producing an added layer of bureaucracy (r'-.ulting in 
loss of productivity), politicizing research (resisting, in 
unproductive conflict), or overly centralizing, c . e • r > 1 (r* llting 


37 


The Autonomy 
of Researchers 
and Providers 


Resource 

Allocation 


in tyranny). It is not sufficient to add or duplicate agencies, 
or functions; one must subtract or integrate them as well. 

Panelists were deeply divided over the extent to which 
researchers and providers should be autonomous or operate 
within a publicly defined context. On the whole, the scales 
were tipped toward the latter view, and for most panelists the 
benefits outweighed the costs. Some panelists mistrusted re- 
searchers and providers, others mistrusted the governmental 
bureaucracy which might be erected to deal with researchers and 
providers, others mistrusted both entities. 

Two opposing views regarding the researcher underly many 
policy choices. To some people the researcher is an individu- 
alist pursuing his own intellectual interests, something of a 
hero contributing to society. They sec management structures 
which tend to direct or control research stultifying the develop- 
ment of new knowledge and harming society in the long run. To 
other people the sane individualistic researcher is an egoist, 
pursuing his own interests at public expense. They see manage- 
ment structures as necessary to make the development of new 
knowledge responsive to the public need and to protect research 
subjects, and benefitting society in the long run. Mediation of 
these conflicting viewpoints will decide the nature, extent, 
and productivity of tomorrow's research system. 

There was substantial agreement for some level of direction of 
research through a national strategy, though panelists varied 
on exactly how much direction. There was disagreement about 


38 


Public 

Participation, 

Information 


the extent to which a national strategy would increase research 
productivity. Medical scientists particularly were inclined to 
be wary of highly directed research believing instead that 
essentially non-directed research was the most productive in 
the long run. There was agreement from all panelists, however, 
that more resources should be spent on health, particularly 
health research. A smaller proportion of research funds than 
at present, however, should be spent on research to develop 
technology and a larger proportion on health services and 
quality assurance research. 

The equitable distribution of health care, particularly 
scarce neitf technologies, will be one of the greatest problems 
facing society in the next 20 years. There is clear preference 
for distributing advances according to need. But how is need 
to be determined? For the most part our knowledge about the 
efficacy of technology is sadly lacking. If potential health 
benefit and need is to be a principal consideration in the 
distribution of technology then we must increase assessment 
activities. We must also develop improved methods of assessing 
the consequences of research, and of using the resultant techno- 
logies. Finally, we must use these new methods of a 
provide the information we need for rational decision-making. 

The public should be encouraged to participate, in policy •ion- 

making to the greatest extent possible. The dls ei (.nation, of 
information — open meetings, publication of evaluations, distri- 
bution of policy related materials — rec i ved high n.iri ! to 
the panel, particularly if the dissemination too', pint t , . 'i 


39 


Individual 
Responsibility 
and Frcedota 


established channels of communication. 

In order that the public be able to make informed decisions 
it should be provided with valid information. Hence the call 
for closer monitoring of research, studies of the implications 
of research, and the evaluation of technologies for safety and 
efficacy. In a’ the government should encourage (or, if 

necessary, mandate) that sufficient information be disclosed 
to the public — through appropriate product labeling, for 
example, or through the disclosure of physician performance 
records. In the same vein, explicitness of policies was seen 
to b« essential. People should know what is being done, how it 
is being done, who is doing it, etc. To foster this, policies 
should be written in lay language; implementation of policies 
should be monitored; evaluations should be conducted by indepen- 
dent third parties to eliminate collusion between regulator 
and regulated. 

The panel emphasized policies that enhanced individual respon- 
sibility and decision-caking, and the dissemination of informa- 
tion. 

The individual snould be responsible for his own actions, 
and should be free to decide what is best provided society has 
no compelling interest in the outcome. Of course, there were 
substantial differences of opinion as to when society's interests 
become compelling. Panelists generally tended to support notions 
of individual freedom, and to dislike excessive governmental 
intervention in private affairs. There is substantial resis- 
tance to extending the hegemony of the Federal government over 


AO 


Minorities 


the private sector (industry, universities, or individual prac- 
titioners), except to control the conduct of research, where 
society's interest in protecting research subjects and its own 
integrity was generally seen to be overriding. 

There is a positive danger that the concern for social good 
can overwhelm and erode individual freedom of choice. To some 
degree, people should be left alone, even if they choose to be 
unhealthy, in the interests of preventing the development of a 
health-oriented totalitarianism. In short, individual freedom 
of choice is more important than research progress or the pur- 
suit of health. 

Panelists’ remarks which addressed the effects of different 
policies on minority or disadvantaged groups (economic, ethnic, 
religious, etc.) generally indicated that minority groups would 
be adversely affected under any set of circumstances. Control 
of advances was frequently seen as serving to restrict or deny 
access to minority groups; promotion of technologies w. is scon 
as leaving minority groups open to various abuses. It is t 
least arguable that this finding reflects a tendency to u • the 
disadvantaged as symbols in making a point — appeals to ii lp 
the downtrodden carry considerable weight. Biomedical and be- 
havioral research and technology exist in a larger cultural and 
social context. If a policy has any potential to harm any group, 
it is likely to harm the disadvantaged to some degree. 


41 


Individual One value conflict was expressed consistently throughout the 

Rights 

Versus findings of the study — that between a concern for individual 

Social 

Need rights and responsibility versus social need and responsibility. 

This conflict was apparent in responses to questions about con- 
trol of behavior, genetic screening, data banks, and illnesses 
caused by personal habits such as smoking and excessive drinking. 
The findings indicate that the notion of responsibility was 
stressed. Where individual resp was involved, as in 

the relationship between smoking and lung cancer or in the 
decision to undergo genetic screening, the panel frequently 
suggested individual solutions. Hie tendency was to prefer 
public education to promote informed choice, rather than to 
enforce regulations to satisfy social need. The public was in- 
clined to allow the operation of individual responsibility in 
such cases a:; the decision to participate in a risky experimental 
treatment, but inclined to enforce conformity to social need 
where an individual's behavior or choice adversely affects others. 

The public's tendency to favor social responsibility was 
apparent in the area of control of violent behavior. The panel 
favored individual responsibility in this area, and the public 
favored social responsibility. Low-incone respondents to the 
national opinion survey — those most likely to be victims of 
violent crimes — tended to favor control. Educated, upper in- 
come, professional respondents — who more closely resemble the 
panel — opposed control. This seems to be another example of 
an increasingly occurring conflict that raises a significant 
question: Who has a better understanding of the problem, the 


42 




Epilogue 


public who experience situations that are studied by researchers, 
or the researchers who study the situations, but are for the 
most part removed from them? 

This conflict suggests the need to provide better public 
information about the possible implications of advances or 
courses of action. However, we must recognize that in the end 
we may face differences in values that cannot be reconciled. 

Advances made possible by medical research in the last 20 
years have changed life for the better, and both public and 
panel expect future advances to bring further improvement in 
the quality of life. The panel agreed, however, that it was 
time for research and researchers to be evaluated and held to 
account; time to involve a more representative group of people 
in research policy decisions; time to set national priorities, 
goals and strategies; and time to reconcile advances in 
technology with the economic, health care, and legal systems. 


43 


Chapter 2: 
Advances. 



45 


INTRODUCTION 


Selection 
of Subject 
Areas 


The implications of advances in biomedical and behavioral 
research and technology were identified using a four— step 
process : 

* Five subject areas in biomedical and behavioral 
research and technology were selected; 

* Three advances were selected and described for 
each subject area, and six scenarios selected; 

* Foreseen implications of the advances and scenarios 
and appropriate policies to respond to then were 
identified in the first Policy Evaluation Instrument 
(PEI) and selected advances from the first PEI were 
brought forward for elaboration in the second; and 

* Panelist responses were summarized and analyzed to 
produce a compendium of implications for each 
subject area. 

These four steps are outlined below; the results of the process 
are described in the remainder of this chapter. A detailed 
description of study methods is provided in Appendix 1. 


An Issues Clarification Meeting was held to select a limited 
number of subject areas for consideration in the study. Ten 
consultant panelists, two from each of the study’s five cate- 
gories of panelist, participated in this meeting. These pane- 
lists identified those subject areas in biomedical and behavior- 
al research and technology that had the potential for signifi- 
cant advances within the next 20 years. They also identified 
the societal concerns (e.g. important values, rights, and pro- 
cesses in society) that would be affected by these advances, 
making the subject area a significant one. Participants ranked 
the subject areas and societal concerns identified according 
to their socio-political importance, and rated the impact of 


46 


Selection 
of Advances 


Identification 

of 

Implications 


the most important subject areas on the most important societal 
concerns . 

The results of the meeting were used to determine the 
minimum number of subject areas, ranked in order of importance, 
that would impact on the maximum number of important societal 
concerns. Following several meetings with Commission staff, 
five subject areas were chosen for study. They were: Systema- 

tic Control of Behavior; Reproductive Engineering; Genetic 
Screening, Extension of Life; and Data Banks, Computer Technol- 
ogy. 

Advances in each subject area were identified by asking at 
least three recognized experts in the subject area to identity 
and describe from three to five advances that were expected to 
occur in the next 20 years, and to rank them in order of impor- 
tance with regard to the impact that the advance would have on 
society. The three most often mentioned advances in each sub- 
ject area were those selected for study. Six scenarios selected 
from 48 scenarios written by members of the SDMG were als 
sidered. Each described a situation brought about by an advance 
that required resolution (one in each subject area and one that 
cut across all subject areas). The fifteen advances (three in 
each of five subject areas) and the six scenarios included In tha 
first PEI are described in Appendix 5. 

In the first PEI all fifteen of the advances were ; and 

panelists were asked to select one advance in each subje< t 
as most important, based upon its implications for so. ii ty. To 


47 


insure that no significant advance had been overlooked, pane- 
lists were asked to describe any advance in each subject area 
which they felt to be equal in importance to those listed. 

Added advances were subsequently compared to those listed in 
the PEI. Figure 1 shows panelists' selections of most important 
advance by subject area and the number of advances added. A 
total of 89 advances were added by panelists; in 59 instances, 
panelists selected the added advance as the most Important ad- 
vance. There was almost no commonality anong the added advances, 
and their implications did not differ materially from those iden- 
tified for the advances listed in the PEI. 

After selecting the most Important advance in each subject 
area, panelists identified, ranked, and described up to three 
significant implications of the advance. Implications were 
structured into seven defined categories. They were: economic, 

ethical, individual, legal, political, social, and technical. 

The implications identified for each advance are shown In Figure 
2. Panelists were also asked to choose from among specific pol- 
icy options which could be adopted with regard to research and 
the implementation of the advance they selected. Panelists' 
choices of policy options are shown In Figure 3. For each of 
the six scenarios panelists were asked to select one of two 
options presented; identify, rank and describe up to three sig- 
nificant implications affecting their choice of option; and 
describe a policy that would be helpful in resolving the issue 
(Figures 4 and 5). 

The second PEI examined the implications of policies that 


48 


Analysis 

of 

Responses 


might be implemented with respect to five advances (one in each 
subject area) brought forward from the first PEI for elabora- 
tion in the second. These advances were chosen because of the 
importance panelists attached to them; the wide range of opin- 
ions held by panelists regarding research and implementation of 
the advance; or to ensure that they encompassed the study's five 
subject areas. They were: Actions of psychopharmacological 

agents further understood; Select-a-boy 3 Select-a-girl market- 
able kits; Amniocentesis becomes routine; Environmental causes 
of disease and. trauma further controlled; and Computerized med- 
ical records in use. 

The five advances were presented in the context of opposing 
policies: (1) promotion of research and implementation; and (2) 

control or limitation of research and implementation of the ad- 
vance. For each advance, panelists were asked to identify the 
policy option they least liked (Figure 6), to indicate up to 
three negative consequences of adopting that particular policy 
(Figure 7), and to identify groups that might be particularly 
affected by these consequences (Figure 8). 

Implications and policies identified by panelists were sorted 
by advance, type, panelist category, and option chosen (where 
relevant). Responses pertinent to each advance and scenario 
were summarized by project staff. These summaries were sent 
to panelist reviewers to identify the dimensions underlying 
panelists' responses. These dimensions were then analyzed to 
identify common themes. The analyses, review materials, the 
original summaries, and individual panelists' responses were 


49 


used as resources for writing this and the subsequent chapter 
of the report. 

The remainder of this chapter summarizes, by subject area, 
the implications of the fifteen advances and six scenarios in- 
cluded in the study. Since the scenario that cut across all 
subject areas (Scenario No. 4, Allocation of Health Services 
Funds) did not raise any extra implications, it is not summarized 
separately. Each set of findings is followed by a brief analy- 
sis and evaluation. The next chapter elaborates on the impli- 
cations of advances for individuals and for society, and for 
moral and ethical issues. 


50 


SYSTEMATIC CONTROL OF BEHAVIOR 

Three advances and one scenario were analyzed and evaluated in 
the subject area Systematic Control of Behavior. They were: 

* Actions of psychopharmacological agents further 
under s tood; 

* Do-it-yourself anxiety and tension reduction; 

* More predictable psychosurgical procedures; and 

* Scenario No. 3, Drug treatments for prisoners . 

Findings All categories of panelist were in substantial agreement regard- 

ing the relative importance to society of the advances. While 
the majority of panelists selected Actions of psychoplvxrmacolog- 
ical agents further understood as the most important advance, 
lawyers selected this advance and More predictable psychosurgi- 
cal procedures in equal numbers (Figure 1). All panelists who 
selected the advance More predictable psychosurgical procedures 
wanted it prevented or controlled, both as to research and imple 
mentation (Figure 3). Representatives of the public interest 
voted f our-to-three against a policy of offering an anti-aggres- 
sion drug treatment to prisoners in exchange for parole, while 
all other panelist categories favored such a policy by about 
two-to-one (Figure 4). 

With respect to research and implementation of psychophanna 
cological agents, all panelists except medical scientists liked 
least a policy of promotion — medical scientists liked least 
a policy of control. Both panelists who least liked promotion 
of this advance and those who least liked control, thought that 
prisoners and residents of health care institutions would be 
particularly affected (Figure 8). 


51 


Four major dimensions were identified in panelists' re- 
sponses in this subject area. They were: 

* The issue of personal feeedom; 

* Society and the question of benefits; 

* Social and political aspects of diversity; and 

* Treatment for symptom or cause. 

The issue of personal freedom . Panelists were divided over 
whether advances in behavior control would enhance or detract 
from individual freedom. One panelist reviewer identified the 
basic conflict as that between those who believe in a holistic 
conception of the human person, with subjectivity and a self- 
image as a responsible person that should be respected and 
fostered, and those who believe a person is a collection of 
"behaviors" that can be manipulated more or less in isolation 
from each other. One panelist (of the former persuasion) remarked 
that the very emphasis on the artificial control of behavior 

in these advances "marks the triumph (but not necessarily the 
truth) of the behavioristic view of man." 

Among the dangers feared, the concept of a person as ready 
for manipulation was very prominent. This concept might lead 
others to be callous in manipulating, and might lead the parson 
to think of himself as a passive object appropriate to be manip- 
ulated. It was alleged to be difficult to square the concept of 
manipulability as a common and decent estate of man with the con- 
cept of individual responsibility. As one panelist said, in ref- 
erence to the anti-aggression treatment, "...afterward the person 
may feel that he is not the real John Jones." There was also 


52 


considerable discussion about the ideals appropriate to human 

life and about how behavioral control advances may trim those 

ideals unnecessarily. One panelist reviewer underscored an 

issue central to this dimension: 

...how to prevent the loss of individuality, responsi- 
bility, freedom of choice while providing assistance for 
those who cannot cope for physical, mental, or social 
reasons with the rigor of life... 

Related to the question of manipulation were twin issues 
of who would undertake the control of behavior and who would 
decide what behavior needed controlling. Panelists argued both 
for freedom of choice in accepting a behavior control technology 
(e.g., an anti-aggression drug), and for limiting access to sucn 
technologies through such means as distribution by prescription. 
There was also concern that institutional keepers would appro- 
priate the technologies and use them without warrant. The 
problem of access was considered exceptionally critical for the 
poor and minorities — these groups might be denied access to 
worthwhile advances, yet be the first chosen for experimenta- 
tion. or widespread use to promote docility. 

The problem of definition and diagnosis of behavioral 
deviance was particularly vexing because our understanding of 
behavior is still primitive. Problems addressed included dis- 
tinguishing between behavior and motive when only behavior is 
treated by the technology, the evolution of social homogeneity 
through behavior control, and the fear that the weak will be 
those most likely defined as deviant. The prospect of govern- 
mental definition of deviance raised the spectre of "1984". 

Society and the question of benefits . Panelists cited bene- 


53 


fits to society generally in terms of reduced costs for custo- 
dial care of criminals and the mentally ill; increased produc- 
tivity through allowing people to overcome problems keeping 
them out of the labor force or below their productive potential; 
and the elimination or curbing of socially costly deviance. How- 
ever, it was also noted that custodians of deviant people may 
be more benefitted than the deviants themselves, that benefits 
could accrue to the pharmacological industry with the potential 
for commercial exploitation, and that researchers might benefit 
by the exercise of their right to pursue knowledge at the ex- 
pense of others. One panelist reviewer noted: 

Panelists warned against the overuse of the advances that 
would consist in social benefits (e.g., docility) being 
given more importance than individual rights; if there 
were an effective anti-aggression drug, for instance, 
it would be tempting to treat disorders that tend to vio- 
lence but themselves are not necessarily violent. 

Social and political aspects of diversity . The potential 

for the surrender of personal control and the development of a 

drug dependent society appeared to many panelists to pose a 

danger to individuals and society transcending any possible 

benefits of the technology. Other panelists, less fearful of 

this eventuality, felt that our society is: the kind that can 

tolerate the introduction of such technologies, and may have 

real need of them. A panelist reviewer observed that 

...diversity, including deviance, is a better path to 
the good society than social management that relies 
heavily on drugs that can easily be misused or have the 
potential to control large populations. 

Some panelists warned that the development of technologies 
for systematic control of behavior, which can be applied on a 


Analysis 

and 

Evaluation 


54 


broad scale, opens the danger for political manipulation or 
abuse. They foresaw great dangers for the lower classes, 
institutionalized populations, political dissenters, social 
deviants, and minority groups, if a dominant elite elected to 
homogenize society. Finally, they theorized that uniformity of 
political, social and personal life could ultimately be demanded. 

Treatment for symptom or cause . Behavior control drugs in 
particular, and control technologies in general, were seen as 
unable to restore "natural" powers of self-control and respon- 
sibility. Therefore, to some panelists they did not represent 
true solutions to problems: 

...[behavior control technologies] are rather vulgar 
techniques for dealing with behavior problems which 
very likely inhere in the social structure in which 
the individual ... resides. 

Another point raised was that some forms of stress may 
be necessary and their avoidance deleterious. Anxiety, for 
example, could have its roots in an ethical problem properly 
responding to the nature of life, and stress could be crucial 
for maturing or learning. Behavior control technologies which 
might merely strengthen people’s weaknesses were viewed with 
alarm, with one panelist noting that an artificially induced 
happiness may be more like the "pig satisfied than Socrates 
dissatisfied" . 

The debate regarding advances in behavior control technologies 
seemed to take place on two levels. On one level there was 
differences of opinion regarding whether behavior control ought 
to be countenanced at all in our society, or whether the whole 


55 


idea of the technology represents "an impiety", in the words of 
one panelist reviewer. On a more pragmatic level, panelists 
faced the existence of the technologies and addressed the ques- 
tion of how they ought to be dealt with in the existing political 
and social climate. 

Nearly all panelists placed great weight on notions of in- 
formed consent and freedom of choice to accept or reject behavior 
control technologies, though freedom of choice was not construed 
to mean free access for everyone. There was concern that informed 
consent would be difficult to obtain in some settings — partic- 
larly institutional settings — which might be inherently coer- 
cive. Can a person suffering a mental illness truly give informed 
consent? In some situations (the treatment of criminals), at 
least some panelists accorded society an overriding interest in 
the behavior of the individual. 

Control of these advances was generally seen as occurring at 
the Federal level. Some felt the regulatory agencies were already 
too subject to professional and industrial influence and wanted 
controls specified in legislation; others looked to the addition 
of interdisciplinary and lay panels to provide public participa- 
tion in whatever decision-making process was accorded responsi- 
bility. Finally, a number of panelists argued that controls 
over behavior control technology were impossible, citing as evi- 
dence the failure to control abuses of alcohol, heroin, and 


tranquilizers . 


56 


REPRODUCTIVE 


Findings 


ENGINEERING 

Three advances and one scenario were analyzed and evaluated 
in the subject area Reproductive Engineering. They were: 

* II 1 vitro fertilization available in clinical practice; 

* Sex selection by sperm separation; 

* Safe 3 simple medical ste'rilization available; and 

* Scenario No. 1 3 Select-a-boy 3 Select-a-girl marketable 
kits. 

The scenario Select-a-boy 3 Select-a-girl marketable kits was 

carried forward from the first PEI for further elaboration in 
the second. 

All categories of panelist were in substantial agreement re- 
garding the relative importance to society of the advances 
(Figure 1). Lawyers tended to like least a policy cf control or 
limitation of marketing the Select-a-boy 3 Select-a-girl kits 3 
while other categories of panelist liked least a policy of pro- 
motion (Figure 6). Panelists selecting either policy option 
generally agreed on the implications of their chosen option and 
on the groups which would be particularly affected (Figures 7 and 
8). In fact, both those in favor of promotion and those in favor 
of control of the kits most frequently identified negative so- 
cial consequences, and mentioned women and young adults among 
the groups most likely to be affected by the policy option chosen. 

Four major dimensions were identified in panelists' re- 
sponses to this subject area. They were: 

* Individual rights and freedom; 

* Social and ethical patterns; 


57 


* Legal, political, and economic issues; and 

* The role of government. 

Individual rights and freedom . The principal beneficial 
effects of reproductive engineering technologies would appear 
to be in increasing, or sustaining, individual rights and free- 
dom. Women would be more free to choose when — or if — to 
have children, through medical sterilization or surrogate moth- 
ering, for example; parents would be free to choose family size 
and composition, through sex selection technology. People would 
be free to sever completely the link between sexuality and 
reproduction. Panelists often mentioned that these freedoms 
were rights. 

There was, however, some ambiguity on the notion of indi- 
vidual rights, as reflected by an apparent conflict between 
rights viewed as absolute, and rights viewed in a social con- 
text. Even among those who tended to see rights as absolute, 
there was a recognition that the rights of one individual can 
clash with those of another — as in family situations where 
conflicting views over sex selection might be held. The exer- 
cise of rights in the context of social structure entailed a 
certain individual responsibility to avoid undercutting "... 
basic social structures and patterns that would be self defeat- 
ing, for then individual rights would have destroyed their own 
basis in society." 

Social and ethical patterns . Many panelists commented on 
the potential effects of reproductive engineering technologies 
on basic social patterns such as the sex ratio, relationships 


58 


between the sexes, forms of marriage and family patterns, and 
the effects on population growth and distribution. Some aspects 
of these technologies were viewed favorably. Sterilization, for 
instance, could help enhance women's control over their own 
lives, and both inexpensive sterilization and sex selection tech- 
nologies could help contribute to the solution of global problems 
of population growth. However, these favorable aspects were 
balanced by a number of concerns. 

Sex selection technologies were of concern because of their 
potential for altering the sex ratio of society — an alteration 
which might be exacerbated among some subcultures which place 
a great value on male offspring. Some panelists viewed this 
potential consequence as a threat to the maintenance of social 
stability. I_n v i tr o fertilization could alter our idea of 
"mothers" and motherhood. All of the technologies in this sub- 
ject area were seen as increasing the sense of separation between 
the procreative and the recreational functions of sex. This 
separation was viewed neutrally in the case of sterilization, 
but in the areas of sex selection and jin vitro fertilization it 
was sometimes seen as commodifying and dehumanizing the procrea- 
tive process. 

Some ethical patterns of American society were considered 
threatened by potential developments in Reproductive Engineering . 
Even the development of such technologies was questioned by 
some panelists who asked whether it was ethical to publicly 
fund research which violates the moral and religious beliefs of 
some, or even many, citizens. The principal ethical questions. 


59 


however, centered around equity and economic justice. 

Equity was at issue throughout all the advances in this 
subject area. Panelists expressed concern that access to some 
scarce technologies (such as in vitro fertilization) might be 
denied some social classes. On the other hand, technologies 
like sterilization or sex selection could be offered coer- 
cively (as a condition of welfare payments, for instance), and 
might be promoted differently among selected classes. The ques- 
tion of economic justice was raised in connection with in vitro 
fertilization where it was suggested that some economic classes 
would be exploited if it became possible for the wealthy to 
buy the services of "surrogate mothers". 

Legal, political, and economic issues . The conflict be- 
tween individual rights and social responsibility gave rise to 
a number of legal, political, and economic issues. For example, 
in sex selection technology individual rights might at some 
time become subject to legal restraint by the state if their 
exercise resulted in massive changes in the sex ratio. In 
other advances, entirely new legal situations might arise (e.g., 
the rights of a surrogate mother to the child, which might en- 
tail a legal definition of "motherhood"). 

Political concern included the potential for intrusion 
of the government into reproductive freedom without overriding 
cause. The totalitarian imposition of sterility, production 
of males for war, and international bargaining with reproductive 
technologies were all seen as possibilities. 

Economic concern tended to center on the potential for 
commercial exploitation of reproductive technologies. Some 


60 


Analysis 

and 

Evaluation 


panelists felt the greed of industry could put potentially prof- 
itable technologies, such as sex selection kits, on the market- 
place before they were fully tested, or sell them at such a 
price as to deny equal access. On the other hand, a number 
of panelists felt there was no problem with commercialization 
of such technologies and that companies should be allowed to 
pursue reasonable profits. These panelists tended to view the 
free market system and individual freedom of choice as suffi- 
cient for controlling advances. 

The role of government . Two views about the role of gov- 
ernment emerged from the panelists' responses. Some panelists 
wanted to minimize the governmental role, restricting it largely 
to the funding of research and implementation. On the other 
side, a number of panelists felt that the government (here 
the Federal government) alone had the power and the resources, 
and was sufficiently representative to be effective in control- 
ling the development of advances. These panelists tended to see 
a governmental role in implementing, directing, and controlling 
the research and application of these advances. There was par- 
ticular concern for the governmental role in monitoring research 
and the consequences of advances, determining public opinion 
about them, and assuming a role in the education of the public 
about the benefits and harms of technologies and publicizing 
the results of monitoring. 

The tension between individual rights and freedom and the good 
of society was manifest throughout the responses to advances in 
Reproductive Engineeriw , and the panel seemed divided on which 


61 


took precedence. This dilemma was remarkable, in itself, be- 
cause in other subject areas panelists more frequently preferred 
to support concepts of individual rights wherever they appeared. 
Two explanations, either alone or in combination, are offered 
to account for this finding. First, the potential social dis- 
ruption foreseen by panelists, should the advances go awry, 
may have been viewed as so extensive as to override individual 
concerns. Second, the exercise of certain rights, such as the 
right to select the sex of a child, may have been viewed as 
stemming from "trivial" personal values. 

Among those panelists who did adhere to a desire for free- 
dom of choice some appeared to do so simply because they felt 
it was right, while others believed that problems inherent in 
the technology would be temporary at best and either self- 
correcting or readily correctable through public policy. Pane- 
lists who foresaw social disruption stemming from an unfettered 
freedom to use reproductive technologies wanted to limit this 
freedom — either to preserve the exercise of other freedoms, 
or to avoid an even greater curtailment of freedom that might 
be necessary should the social disruption they foresaw come to 


pass . 


62 


GENETIC SCREENING 

Three advances and one scenario were analyzed and evaluated 
in the subject area Genetic Screening. They were: 

* Amniocentesis becomes routine; 

* Widespread screening for inborn errors of metabolism; 

* Research shows lung cancer s heart disease have genetic 
basis; and 

* Scenario No. 5, Marketing of a group insurance plan 
with genetic screening . 

The advance Amniocentesis becomes routine was carried forward 
from the first PEI for elaboration in the second. 

Findings All categories of panelist were in substantial agreement re- 

garding the relative importance to society of the advance. How- 
ever, a plurality of ethicists selected Widespread screening for 
inborn errors of metabolism as the most important advance, while 
a plurality of all other categories of panelist selected Amnio- 
centesis becomes routine (Figure 1). Lawyers were slightly in 
favor of allowing the Marketing of a group insurance plan with 
genetic screening 3 while all other panelist categories opposed 
this action by nearly two-to-one (Figure 4). 

Panelists split evenly in their choice of a least liked 
policy for the advance Amniocentesis becomes routine. However, 
regardless of the least favored policy option, either promotion 
or control, panelists most frequently predicted negative social 
consequences and tended to agree that women and low income people 
would be particularly affected (Figures 7 and 8). 

Four major dimensions were identified in panelists' responses 
in this subject area. They were: 


63 


* Individual rights and responsibilities; 

* Social and ethical aspects of screening; 

* Short terra health considerations; and 

* Long term health considerations. 

Individual rights and responsibilities . Individuals were 
viewed as having "rights" to the kind of information provided 
by screening which may be necessary to make informed choices 
about procreation. These rights were often associated with 
notions of taking personal responsibility for decision-making. 
However, there was a countervailing thought that the individ- 
ual's rights included the right not to seek the information 
and that this personal responsibility could be perverted or 
denied. Pressures on the individual in the form of direct 
coercion by government or commercial interests (manipulating 
subsidies for screening and abortion;, or indirect coercion 
through social pressures or the advice of physicians, were seen 
as real possibilities. In general, as a panelist reviewer 
noted, 

...when confronted with genetic disease (real or 
imagined), the rights of the mother were considered 
weightier than the rights of the fetus. In the same 
confrontation, however, the rights of the fetus were 
considered weightier than the rights of society. 

Thus panelists tended to support strongly concepts of freedom 
of choice both in the decision to seek — or not to seek — 
screening, and in decisions on what to do about the information 
found through screening, while condemning social or political 
pressures which might affect that choice. Physicians were con- 
sidered as a special class here, with some panelists wondering 


64 


about the legal vulnerability of physicians who did not pre- 
scribe amniocentesis, in the event of the birth of a child with 
genetic defects that could have been detected by the test. 

Social and ethical aspects of screening . The relationship 
between screening technologies and abortion as a resulting 
therapeutic intervention lies .at the base of many concerns about 
the social aspects of screening. Abortion of defective fetuses 
was viewed favorably in that it could decrease the cost of care 
(custodial or treatment). Some argued that it was imperative to 
avoid these costs, which were generally seen as rebounding onto 
society when they reached the point beyond a family’s ability 
to sustain the costs by itself. Screening and abortion were 
viewed much less favorably as they related to perceived social 
pressures . 

Panelists were concerned that the identification of defec- 
tives could only bolster a growing notion that abortion is a 
responsible and acceptable course of action, which would inten- 
sify pressures on those morally or religiously opposed to it. 

The birth of a significantly defective child is a 
major emotional tragedy for the parents. The burden 
would increase if such a child were to be born at a 
time when a general attitudinal message might say: 
you could have easily prevented this event. 

Increased acceptance of abortion could lead to promoting the idea 

that it is a community obligation, labelling religious or moral 

scruples as "selfishness", or stigmatizing people who refused to 

undergo screening or accept an abortion. 

Concern was also apparent for the existing population of 

"defectives" and for those who might "slip through the net" of 


65 


screening technologies. Some panelists feared that society 
might lose the will (and possibly the incentive) to provide con- 
tinued support as notions of "preventability" came to the fore, 
and that the fewer defectives, the greater the stigma for those 
who remained. 

A host of other considerations were offered, ranging from 
the costs of instituting screening programs and offering them 
on an equitable basis, to concerns about the disruption of pro- 
creative rights, and effects on mate selection. There was even 
fear that screening could result in the emergence of a class 
of social outcasts, which could jeopardize the structure of 
American democracy. 

Short term health considerations . Proponents of screening 
technologies cited favorable short-term health implications in 
support of their position. The mental health of individuals 
and families would be aided by positive knowledge of the health 
of a fetus, and people identified as genetic risks could choose 
to modify their lifestyles appropriately. Opponents of the 
technologies cited diagnostic errors (false positives and false 
negatives), potential iatrogenic damage from invasive techni- 
ques such as amniocentesis, and adverse affects on mental health 
stemming either from being identified as a carrier or from 
guilt about abortion. 

Either way, panelists noted, the burden would be particular 
ly heavy on the poor. The poor would suffer if screening tech- 
niques like amniocentesis were routinely done because abortion 
and other needed services are not equally accessible to everyone 


66 


Analysis 

and 

Evaluation 


the poor would suffer if amniocentesis were not routinely avail- 
able because only the wealthy would be able to make use of it. 

Long term health considerations . Long term consequences of 
screening programs were related to the genetic integrity of future 
generations. Proponents of screening saw the creation of healthy 
human progeny as a worthwhile goal unto itself. Some noted that 
prevention of the transmission of genetic disease would result 
in overall improvements in the genetic health of the population. 
They also suggested that widespread comprehensive screening pro- 
grams would tend to identify everyone as, in some sense, geneti- 
cally imperfect, which would help allay problems of stigmatiza- 
tion and represent something of a natural check on promoting 
wholesale eugenics programs. 

Opponents were not so certain that only better genetic 
health was at issue. To this group, the striving toward nor- 
mality suggested by proponents could easily be turned into a 
search for perfection. As a panelist reviewer noted, procrea- 
tion could become "...a yoke, a commodification process in which 
the perfect are acceptable, but the imperfect are to be regarded 
as 'factory rejects'." This group seemed to view normality as 
less a fixed notion than a transient concept affected by changes 
in social values. 

The principal issues in genetic screening appear to be the 
trade-offs which would occur between individual rights and the 
public good, and, to a lesser extent, the resolution of problems 
about long-term genetic change and about equity in distributing 
the technology. For most panelists, the public good tended to 


67 


be considered less Important than the rights of either the 
mother or the fetus, and there was also substantial agreement 
that equity in distributing the technology was necessary to pre- 
vent differential birth rates of children with genetic defects 
among particular ethnic or economic minorities. The problem 
of long-term genetic change would appear to be ameliorated so 
long as the freedom to choose could operate untainted by social, 
governmental, or economic pressures to follow a particular 
course of action. 

While analysis of the responses in the subject area of 
Genetic Screening revealed considerable disagreement on a num- 
ber of issues, a panelist reviewer identified five ideas com- 
mon in responses to the advance Amniocentesis becomes routine 
which seemed to transcend Individual panelists' positions on 
policy. First, there should be public education about the bene- 
fits and risks, with appropriate identification of high risk 
categories, and differential promotion in these categories. 
Second, there should be increased resources for genetic coun- 
seling to buttress the education program. Third, there should 
be assurance of continued funding for the care of defectives 
to insure that the option to decline screening and abortion was 
equally as viable as the option to accept. Fourth, there should 
be freedom of choice and informed consent procedures established 
in connection with amniocentesis and appropriate government 
subsidy to insure equitable distribution. Fifth, there should 
be standards of quality control governing the facilities and 
personnel administering the screening technology. 


68 


EXTENSION 


Findings 


OF LIFE 

Three advances and one scenario were analyzed and evaluated in 
the subject area Extension of Life. They were: 

* Compact^ wearable 3 artificial kidney developed; 

* Enviro-nmental causes of disease and trauma further 
controlled; 

* Gene therapy now available; and 

* Scenario No. 6 3 Life and death decisions . 

The advance Environmental causes of disease and trauma further 
controlled was carried forward from the first PEI for elabora- 
tion in the second. 

All categories of panelist were in substantial agreement re- 
garding the relative importance to society of the advances 
(Figure 1). In the scenario, representatives of the public 
interest were somewhat more inclined than the other groups to 
allow a panel of persons to decide the fate of a patient on a 
life support system (Figure 4). Lawyers and medical scientists 
were about evenly divided over policies of promotion or control 
of research and implementation regarding Environmental causes 
of disease and trauma 3 while over 70% of other panelists were 
against a policy of control (Figure 6). 

There were also some differences in the response which did 
not depend upon panel category but on the policy option chosen. 
For instance, 24% of panelists who liked least a policy of con- 
trol of research and implementation of the advance Environmental 
causes of disease and trauma further controlled foresaw negative 
health consequences arising from such a policy, while none of 


69 


the panelists least favoring a policy of promotion noted nega- 
tive health consequences (Figure 7). The groups particularly 
affected also differed according to the policy option chosen for 
this advance, with panelists who least liked a policy of control 
more frequently mentioning urban populations, workers, and low- 
income people, while those least liking a policy of promotion 
tended more to mention private industry and low-income people 
(Figure 8). 

Four major dimensions were identified in panelists’ re- 
sponses in this subject area. They were: 

* Allocation or redistribution of resources; 

* Equal access to technology; 

* Government regulation of development; and 

* Education versus regulation. 

Allocation or redistribution of resources . Technologies in 
the subject area Extension of Life seemed to raise a variety of 
questions about resource allocation. Some panelists addressed 
the problems of "half-way" technologies (e.g., expensive life 
sustaining machinery), that extend life but do not restore the 
patient to his previous health status. They noted that invest- 
ment in these developments required taxing the many for the 
support of the few. Allocation was also cited as a problem 
when it related to the assignment of scarce resources to those 
in need — either the assignment of life saving equipment, or 
the allocation of funds to clean up particular environmental 
problems. Deciding on resource allocations between prevention 
and cure was underscored with respect to Environmental causes 
of disease and trauma further controlled , where panelists disa- 


70 


greed on which would be the more costly approach. One view had 
it that "...pure air and water may be too much to be affordable," 
while the other felt the cost of comprehensive programs for pre- 
vention of environmental harms would be cheaper than paying on 
a piecemeal basis. 

Redistribution of resources was noted with respect to 
changes in population composition and location, and with respect 
to the distribution of funds for particular technological enter- 
prises. Technologies which extended life at the later end of its 
span have the potential for increasing the proportion of older 
people. This may require redistribution of either money or 
jobs, and could accentuate conflict between generations. Tech- 
nologies associated with environmental problems may have the 
effect of relocating people either aw ay from high risk areas 
or out of dangerous industries. Allocative decisions between 
crisis intervention modes of medical treatment and preventive 
measures, such as education, also represent redistributive ques- 
tions . 

Equal access to techn o logy . Panelists were concerned that 
investments in expensive life-saving technologies may produce 
advantages only for the wealthy few. At the same time, there 
seemed to be little interest in providing extensive funding for 
development of these technologies. Benefits were only foreseen 
under the circumstances that a large number of people could be 
"normalized". However, this would involve large-scale public 
funding. With respect to environmental manipulation, problems 
of equal access related to availability of information and 


71 


funds for improving the environment. The basic concern was 
for equity in deciding how, where, and when changes would be 
made . 

Government regulation of development . The question of gov- 
ernment involvement ran throughout the advances in Extension of 
Life. In general it appeared that panelists ceded decision-mak- 
ing authority to the government either because it was the only 
likely source of funding, because it alone had the necessary 
authority, or becuase of a distrust of industry. In the case 
of the artificial kidney, the government was the source of funds, 
hence the source of the allocation decision. In the case of 
environmental causes of disease, only the government (generally 
the Federal government) could exercise power at a level suffi- 
cient to accomplish change. In gene therapy, the potential harms 
appeared so great that the government was called upon for protec- 
tion. The distrust of industry manifested in environmental 
areas, and to a lesser extent in gene therapy, was not univer- 
sally held. Some panelists feared that business could become 
"...a whipping boy and enemy of good environment", which would 
jeopardize the free enterprise system and encourage greater 
public control. 

The problem foreseen in extending government regulation 
was the concomitant loss of individual freedom. This was held 
as particularly true in Environmental causes of disease o:n£ 
trauma further controlled 3 where panelists cited examples of 
air bags for cars and restrictions on smoking as intrusions on 
individual freedom. Conflict seemed to exist in this area be- 
tween seeking government protection in areas beyond the indivi- 


72 


Analysis 

and 

Evaluation 


dual's power to control, while at the same time fearing the loss 
of individual freedom. Thus, government protection was sought 
against polluting industries but avoided if it had to do with 
enforcement of an altered personal lifestyle; the zeal to im- 
prove overall health should not seriously infringe on individual 
rights . 

Education versus regulation . Although there was wide- 
spread appeal to the government as a source of regulation, not 
all government activity was seen as regulatory. Particularly, 
with respect to policy approaches for further controlling Envir- 
onmental causes of disease and trauma 3 panelists recommended a 
strong role for the government in providing education about life 
styles and their consequences. The concern for education itself 
seemed a response to the concern over increasing Federal encroach- 
ment on individual freedom. In general, the notion of education 
was tied to policies for promoting research that would lead to a 
new and better knowledge about environmental processes and effects 

Throughout this subject area, panelists tended to see issues 
more as trade-offs than as pros and cons. Some of the trade- 
offs noted were: investing in life-saving equipment versus pre- 

ventive medicine; preventing technological development versus 
developing expensive technologies, then providing them univer- 
sally, and stopping pollution versus the cost of industrial (and 
economic) dislocation. 

Perhaps out of this sense of multiple trade-offs and the 
problems of making allocations of one kind or another, the panel 
frequently looked to appropriate sources of authority. In the 


73 


scenario which depicted a life and death decision they debated 
whether a physician or a representative panel was the appropriate 
source of authority. With respect to the advances themselves 
there was more agreement. Panelists suggested the government 
would have to mediate many of the questions, or, by educating 
the public, help individuals to regulate themselves, e.g. , as 
regards smoking. 

Sometimes the questions became so complex that the nature 
of the trade-offs became obscured. The pursuit of research into 
environmental causes of disease would mean an added tax burden, 
both on wage-earners and on industry, which could undercut 
economic growth. Failure to pursue suv' - reseu •'h would mean 
continuation of double costs — payment C'-r produ-.ts of industry 
and payment for medical costs caused by environmental deteriora- 
tion. As one panelist observed, "...it is not whether there 
are costs on one side md no costs on the other. The issue is, 
which cost •/ill be borne by whom?" 


74 


DATA BANKS, 


Findings 


COMPUTER TECHNOLOGY 

Three advances and one scenario were analyzed and evaluated in 
the subject area Data Banks 3 Computer Technology. They were: 

* Computerized medical records in use j 

* Computer simulates metabolic processes 3 aids patients ; 

* Computer screens patients 3 provides check-ups; and 

* Scenario No. 2 3 Hospital responsibility for physician 
performance data. 

The advance Computerized, medical records in use was carried for- 
ward from the first PEI for e oration in the second. 

All categories of panelist ere in substantial agreement re- 
garding the relative importance of the advances (Figure 1). 

In the scenario, a majority of medical scientists (57%) thought 
that hospitals should not be responsible for informing prospec- 
tive patients about data on physician performance, while 80% 
or more of each of the other four categories of panelist favored 
such responsibility (Figure 4). 

Ethicists and social scientists most often liked least 
a policy of promotion of Computerized, medical records in use 3 
while the other three categories of panelist most often liked 
least a policy of control or limitation. In the case of the 
ethicists the vote was over two-to-one against their use 
(Figure 6). There was also a very apparent difference in the 
negative consequences foreseen for Computerized inedical records 
in use 3 depending upon the policy option chosen. Panelists who 
liked least a policy of promotion of this technology more fre- 
quently foresaw negative ethical consequences. Panelists who 


75 


liked least control of the technology overwhelmingly identified 
negative technical consequences (Figure 7). Low income people, 
chronically ill people, and physicians were the groups panel- 
ists mentioned most often as those likely to be particularly 
affected by the negative consequences of the technology — 
whether it was promoted, or limited or controlled (Figure 8). 

Five major dimensions were identified in panelists' re- 
sponses to advances in this subject area. They were 

* Privacy and personal control; 

* Quality and cost of health care; 

* Broad health coverage and equitable distribution; 

* Changes in the physician-patient relationship; and 

* Long range planning and research. 

Privacy and personal control . Comments about privacy, 
as it relates to developments in computer technology, were uni- 
versally negative. Even proponents of the technologies admitted 
the potential existed for invasion of privacy and that this 
would particularly affect the poor and minorities. Proponents 
tended to view the potential benefits, both for individuals and 
for society as a whole, as overriding any slight loss of per- 
sonal privacy or autonomy. Countervailing this was a sense 
among opponents that developments in computer technology could 
erode the value for privacy and confidentiality by fostering 
notions of the acceptability of trade-offs between these rights 
and some presumed set of benefits. 

Some panelists expressed a concern for privacy so strong 
that with respect to computerized medical records they suggested 


76 


patients be the ultimate "owners" of the record, controlling 
access to it and making changes in it themselves. Violation 
of confidentiality was seen as resulting in a host of problems. 

For example, the labelling of groups by health status could be 
used to classify workers, or even to develop new principles of 
social stratification. 

The extent of opposition to computer technologies involving 
data gathering and storage was underscored by a panelist re- 
viewer who observed: 

The potential for governmental, medical (research), 
and commercial (employment and insurance) intrusion 
and exploitation of individuals and groups was con- 
sidered so great by so many panelists, and [the] ame- 
liorative policies so overwhelming, that virtually 
all possible benefits to society and individuals would 
be eradicated. 

While panelists seemed to be of one mind regarding the 
dangers of invasion of privacy (though divided over whether the 
potential harms were greater or less than the benefits), they 
viewed the relationship between developments in computer tech- 
nology and its effects on personal control more equivocally. 
Computer technologies could lead to increased patient responsi- 
bility, improved patient self-image, the demystification of 
medicine, and increased patient independence. On the other 
hand, a system could develop where patients had to submit to 
computerized screening prior to receiving care, and patient 
care could be come increasingly impersonal and mechanistic. 

Quality and cost of health care . Both positive and negative 
effects on the quality and cost of health care were foreseen 
with respect to advances in this subject area. Positive bene- 


77 


fits were claimed for those aspects of computer technology 
which might reduce the cost of care, insure completeness in 
the medical record, increase the speed and ease of access to 
records, decentralize facilities, improve quality control of 
health care providers, educate patients, and establish con- 
tinuity of care. The efficiency of computerized record systems 
and computer conducted check-ups were also viewed as helping 
to release physician time for more personal patient care by 
avoiding duplication of tests or the handling of routine visits. 
Patient populations considered to be particularly benefited by 
these developments included the elderly, poor or itinerant pa- 
tients (particularly the peripatetic middle class), and patients 
with complex, multisystemic diseases. 

Negative aspects of computer technology noted by the panel- 
ists included those that would arise through higher costs occa- 
sioned by the use of capital intensive equipment, and enhance- 
ment of a mechanistic view of patients as machines to be re- 
paired, a loss of intimacy and trust in the physician-patient 
relationship, and outright harm perpetrated through errors in 
programming or input to medical records. More subtle effects 
might occur through the tendency to some patients to avoid use 
of the technologies. The poor, minorities, and the less edu- 
cated were seen as particularly likely to either avoid using 
the technology, or be incapable of using it to its potential. 

Broad health coverage and equitable distribution . Panel- 
ists noted that hard policy choices would have to be made be- 
tween emphasizing care for the greatest number versus directing 


78 


attention to long-term,, life-saving research. A panelist re- 
viewer asked, "...will our efforts to improve quality truncate 
the distribution [of advances], or will our emphasis on equity 
impair overall health services?" Computer technologies could 
help broaden the base of health care by allowing more people 
to be served and served better, but they could also lead to 
inequities. At the worst, the technology was seen as harboring 
the potential for developing a two-class system. Such strati- 
fication might be based on wealth where one class would be able 
to seek and pay for high quality, personalized health care; it 
might be based on sophistication where the less sophisticated 
would avoid the mechanistic technology; or it might be based 
on fear of exposure where patients with potentially stigma- 
tizing diseases would avoid seeking treatment. 

According to some panelists, the publication of physician 
performance records could lead to the stratification of prac- 
titioners with those highly rated charging high fees to those 
able to afford them, leaving lower-rated physicians to serve 
the poor and posing problems for the equitable distribution of 
health care. As a panelist reviewer noted: 

Everyone wants the best: not everyone can have 

the best: not everyone is the best. These are the 

facts. Any suggested information about a physician’s 
performance would naturally divert people away from 
some and towards others merely on the basis that some 
perform better but not because any are unqualified. 

The resultant heavier load on the select few leaves 
many unused and underused, a situation we can ill 
afford. 

Changes in the physician-patient relationship . Both the 
advances and the scenario raised questions about the nature and 


direction of changes in the physician-patient relationship. 
Computerized check-up and screening systems, computerized 
medical records, and hospital release of physician performance 
information raised issues of the depersonalization of the 
physician-patient relationship, the development of a climate 
of mistrust, and the addition of a third entity into the tradi- 
tional two-party relationship. Panelists held differing views 
on whether such changes would be for the better or the worse. 

Some panelists noted that these advances would help to 
demystify medicine and promote individual responsibility for 
health by providing patients with better information and more 
direct control over their own health care. Others in favor 
of the advances suggested that physicians would have more time 
to devote to personal relationships with their patients if com- 
puter technology were able to handle some routine aspects of 
practice. 

The view of those in opposition to the technologies was 
that the introduction of mechanistic technologies into day- 
to-day medical practice would separate the patient further 
from the physician. Depersonalization, and mistrust created 
by such things as concern over leakage of medical records or 
knowledge about the physician's performance record, would be 
accompanied by a lower quality of health care, according to 
these panelists. 

Long range planning and research . The discussion of 
advances in computer technology generally emphasized the long 
term preventive approach to medicine rather than the short 


80 


Analysis 

and 

Evaluation 


term therapeutic approach — though this was not an exclusive 
focus. Panelists singled out preventive medicine, public 
health planning, and epidemiology as areas which might be 
particularly benefited by advances in computer technology. 
Continuity of care would promote preventive medicine and togeth- 
er with an increased climate of personal responsibility for 
health care, could help loiter the total costs of care. The 
aggregated data in computerized systems would also be valuable 
for epidemiological research, and ultimately for preventive 
medicine. The study of rare diseases would be aided, and new 
insights gained into the etiology of diseases. Public health 
planners would have aggregated data for performing cost-benefit 
analyses, and for effecting a better distribution of personnel 
and facilities. Caveats mentioned in this area related to 
the "Achilles heel" of computer technology — input accuracy 
— and some panelists considered claims for these planning 
and research benefits overblown, if not unfounded. Such uses 
of computer technology as auditing the performance of practi- 
tioners, developing profiles of physicians, and building a 
data base on medical practices and their outcomes were viewed 
with mixed emotions. Some saw benefits from these practices 
(e.g., improved quality control) others saw harms (e.g., viola- 
tion of the privacy of physicians). 

The implications of advances in this subject area seemed to 
hinge on panelists' views of equity and the values held about 
technological progress and social concern. The issue of equity 
was quite clear when panelists were concerned about a high cost 


81 


technology that appeared to be especially prone to distribution- 
al inequities, such as computerized aids to organ function. 

Less clear was the question of technological progress and 
social concern and the interaction of these issues with ques- 
tions of equity, which appears to characterize advances in- 
volving more widespread applications of computer technology. 
Proponents of technologies such as computerized medical records 
generally alluded to such technological benefits as improved 
planning, research, and patient care. Social concerns, such 
as the invasion of privacy, were either muted by the assump- 
tion that safeguards could be provided, or accepted as an 
intrinsic cost of the advance. Equity in distribution seemed 
to be assumed. Opponents of these technologies were unwilling 
to accept the trade-off of privacy for progress, and some con- 
sidered the technology inherently inequitable because many 
people would be either unwilling or unable to use it. The 
policy problem raised was one of maintaining a balance between 
technological benefits and social harms while simultaneously 
insuring equitable distribution. 

The advance Computerized medical records in use illus- 
trated a degree of mistrust of established institutions on the 
part of panelists. Opposition to record systems was frequently 
based on a distrust of government or commerical interests that 
might abuse individual privacy. Proponents of the record sys- 
tems often seemed to favor them for their potential to monitor 
physician performance, reflecting "...an intrinsic mistrust of, 
the medical profession," according to one panelist reviewer. 


82 


Figure 1 


MOST IMPORTANT ADVANCE IN EACH SUBJECT AREA BY PANELIST, FIRST PEI (1) 


Category of Panelist (2) 


Subject /treat Advance Selected (3) 



Systematic Control of Behavior 

Actions of psychopharmacological agents further 
understood . 

Do-it-yourself anxiety and tension reduction ... 

More predictable psychosurgical procedures 

Added advances 

Total 

Reproductive Engineering 

In-vltro fertilization available in clinical 
practice 

Sex selection by sperm separation 

Safe, simple medical sterilization available ... 

Added advance 

Tolal 

Genetic Screening 

Amniocentesis becomes routine 

Widespread screening for inborn errors of 
metabolism 

Research shows lung cancer, heart disease have 
genetic basis 

Added advance 

Total 

Extension of Life 

Compact, wearable, artificial kidney developed . 

Environmental causes of disease and trauma 
further controlled 

Gene therapy now available 

Added advance 

Total 

Data Banks, Computer Technology 

Computerized medical records in use 

Computer simulates metabolic processes; aids 
patients 

Computer screens patients, provides check-ups .. 

Added advance 

Total 


11 

6 

1 

A 

22 

5 

A 

11 

2 

22 

9 

10 

3 

0 

22 

2 

13 

3 

A 

22 

13 

2 

5 

2 

22 


5 11 10 11 

2 3 3 2 

5 A 5 3 

2 2 2 A 

1A 20 20 20 


2 2 13 

1 A 6 5 

9 13 12 9 

2 113 

1A 20 20 20 

8 10 8 9 

3 7 3 6 

3 3 6 A 

0 12 1 

1A 21 19 20 

2 10 0 

9 10 15 10 

2 6 A 2 

1 A 2 8 

1A 21 21 20 

9 13 15 9 

2 2 0 0 

2 3 3 6 

13 2 5 

1A 21 20 20 


A8 50% 

16 17% 

18 19% 

1A 15% 

96 100% 

13 1A% 

20 21 % 

5A 56% 

9 9% 

96 100% 

AA A6% 

29 30% 

19 20% 

A A% 

96 100% 

5 5% 

57 58% 

17 17% 

19 19% 

98 100% 

59 61% 

6 6 % 

19 20% 

13 13% 

97 100% 


(1) 98 of 129 panelists (76%) completed the first PEI. 

(2) Self-assigned categorization. 

(3) See Appendix 5 for the full description of each advance. 


83 


Figure 2 

SIGNIFICANT IMPLICATIONS OF ADVANCES BY SUBJECT AREA, FIRST PEI 



Systematic Control of Behavior 


Actions of psychopharmacological agents further 
understood (N=48) 

27 

38 

75 

25 

23 

65 

29 

Do-it-yourself anxiety and tension reduction 
(N=16) 

31 

25 

63 

63 

13 

100 

19 

More predictable psychosurgical procedures (N=18) 

0 

72 

72 

61 

28 

28 

11 

Reproductive Engineering 








In-vitro fertilization available in clinical 
practice (N-13) 

39 

69 

31 

31 

0 

37 

0 

Sex selection by sperm separation (N=20) 

30 

50 

45 

5 

8 

95 

15 

Safe, simple medical sterilization available 
(N=54) 

37 

56 

70 

26 

24 

72 

7 

Genetic Screening 








Amniocentesis becomes routine (N=44) 

30 

86 

57 

39 

2 

43 

7 

Widespread screening for inborn errors of 
metabolism (N-29) 

21 

62 

86 

35 

14 

59 

35 

Research shows lung cancer, heart disease have 
genetic basis (N=19) 

42 

16 

68 

5 

16 

68 

26 

Extension of Life 








Compact, wearable, artificial kidney developed 
(N=5) 

100 

60 

0 

20 

40 

40 

20 

Environmental causes of disease and trauma 
further controlled (N=57) 

84 

18 

25 

21 

54 

61 

18 

Gene therapy now available (N=17) „ 

35 

59 

71 

18 

18 

53 

24 

Data Banks , Computer Technology 








Computerized medical records in use (N=59) 

39 

20 

54 

29 

17 

68 

63 

Computer simulates metabolic process; aids 
patients (N=6) 

83 

83 

50 

17 

17 

33 

17 

Computer screens patients, provides check-ups 
(N=19) 

68 

21 

58 

5 

0 

58 

63 


(1) Percentage of panelists selecting an advance who indicate the type of implications among 
the three most significant implications of the advance for society. 

(2) "N" indicates the number of panelists who selected the advance as the most important 
one in a subject area. 

(3) See Appendix 5 for a full description of each advance. 


84 


Figure 3 



Systematic Control of Behavior 


Actions of psychopharmacological agents 
further understood (N>*48) 

40 

15 

29 

2 

8 

6 

0 

Do-it-yourself anxiety and tension reduc- 
tion (N“16) 

13 

38 

13 

13 

6 

19 

0 

More predictable psychosurgical procedures 
(N=18) 

100 

0 

0 

0 

0 

0 

0 

Reproductive Engineering 

In-vitro fertilization available in clinical 
clinical practice (N=12) 

67 

8 

8 

0 

0 

16 

0 

Sex selection by sperm separation (N=20) .. 

55 

0 

20 

15 

5 

0 

5 

Safe, simple medical sterilization 
available (N=54) 

17 

35 

20 

2 

9 

17 

0 

Genetic Screening 

Amniocentesis becomes routine (N=42) 

12 

24 

31 

2 

10 

21 

0 

Widespread screening for inborn errors of 
metabolism (M=26) 

35 

8 

35 

8 

12 

4 

0 

Research shows lung cancer, heart disease 
have genetic basis (N=17) i. 

6 

59 

18 

6 

6 

6 

0 

Extension of Life 

Compact, wearable, artificial kidney 
developed (N=5) 

20 

40 

20 

0 

0 

0 

20 

Environmental causes of disease and trauma 
further controlled (N=57) 

5 

46 

12 

0 

32 

5 

0 

Gene therapy now available (N=17) 

59 

12 

24 

0 

6 

0 

0 


Data Banks , Computer Technology 


Computerized medical records in use 

(N=57) 

19 

11 

28 

5 

33 

4 

0 

Computer simulates metabolic process 
patients (N=6) 

; aids 

33 

33 

0 

0 

33 

0 

0 

Computer screens patients, provides 
ups (N=19) 

check- 

11 

21 

26 

11 

26 

5 

0 


(1) Policy approaches were discerned by analyzing panelists* separate votes on (1) policy 

with respect to research, and (2) policy with respect to implementation. Research 
policy options were: prevent; control; allow; promote. Implementation policy options 

were: prevent; control; evaluate; allow; promote use by people who need it; promote 

for use by people who want it. 

(2) Percentage of panelists selecting the policy approach for each advance. Rows sum 
to 100%. 

(3) See Appendix 5 for a full description of each advance. 

(4) "N" indicates the number of panelists who selected the advance as the most important 
one in a subject area, and a prefered research and implementation policy. 


85 


Figure 4 



Scenario .7 o. 1: Seleci-a-Boj, Sc leer-:;- it; 

Marketable Kits 

r»7 







Allow marketing of kits 

11 

7 

8 

10 

11 

47 

49% 

Do not allow marketing of kits 

11 

7 

13 

10 

8 

49 

51% 

Total 

22 

14 

21 

20 

19 

96 

100% 

Scenario Mo. 2: Hospital Responsibility 

for Physician Performance Data 








Hospitals should be responsible .... 

17 

12 

9 

17 

16 

71 

74% 

Hospitals should not be responsible 

4 

1 

12 

4 

4 

25 

26% 

Total 

21 

13 

21 

21 

20 

96 

100% 

Scenario Do. 3: Drug Treatment for 

Prisoners 








Treatment should be allowed 

15 

10 

14 

8 

12 

59 

62% 

Treatment should not be allowed .... 

7 

4 

7 

12 

7 

37 

39% 

Total 

22 

14 

21 

20 

19 

96 

100% 

Scenario Mo. 4: Allocation of Health 

Services Funds 








University Hospital receives funds . 

4 

6 

6 

4 

8 

28 

33% 

Neighborhood health clinic receives 
funds 

17 

8 

10 

13 

9 

57 

67% 

Total 

21 

14 

16 

17 

17 

85 

100% 

Scenario Ho. S: Marketing of a Croup 

Insurance Plan with Genetic Screening 








Insurance commissioner should 
approve marketing 

7 

8 

8 

6 

7 

36 

38% 

Insurance commissioner should not 
approve marketing 

14 

6 

13 

14 

12 

59 

62% 

Total 

21 

14 

21 

20 

19 

95 

100% 

Scenario Ho. S: Life or Death 

Decisions 








ICU physician should decide 

11 

5 

8 

4 

7 

35 

40% 

Panel of persons should decide 

11 

6 

11 

13 

11 

52 

60% 

Total ...» 


11 

19 

17 

18 

87 

100% 


(1) Self-assigned categorization 

(2) See Appendix 5 for a full descri; jn of each scenario. 


86 


Figure 5 

SIGNIFICANT IMPLICATIONS OF SCENARIOS, BY OPTION CHOSEN, FIRST PEI 



Scenario No. 1: Select- A-Boy , Select- A- 

Girl Marketable Kits 


Allow marketing of kits (N=47) 

19 

43 

75 

17 

11 

62 

13 

Do not allow marketing of kits (N=49) 

16 

61 

45 

4 

18 

94 

20 

Scenario No. 2: Hospital Responsibility 

for Physician Performance Data 








Hospitals should be responsible 
(N=71) 

14 

52 

51 

70 

9 

54 

13 

Hospitals should not be responsible 
(N=25) 

12 

52 

44 

80 

8 

40 

20 

Scenario No. 3: Drug Treatment for 

Prisoners 








Treatment should be allowed (N=59) . 

34 

51 

76 

36 

7 

68 

9 

Treatment should not be allowed 
(N=37) 

8 

46 

76 

57 

30 

60 

14 

Sceruario No. 4: Allocation of Health 

Ser’jices Funds 








University Hospital receives funds 
(N-28) 

75 

21 

21 

0 

21 

50 

68 

Neighborhood health clinic receives 
funds (N=57) 

74 

40 

9 

2 

39 

67 

9 

Scenario No. 5: Marketing of a Group 

Insurance Plan with Genetic Screening 








Insurance commissioner should 
approve marketing (N=36) 

64 

44 

50 

14 

14 

44 

11 

Insurance commissioner should not 
approve marketing (N=59) 

31 

75 

' 75 

36 

9 

44 

2 

Scenario No. 6: Life or Death 

Decisions 








ICU physician should decide (N=35) . 

20 

63 

40 

34 

6 

54 

6 

Panel of persons should decide (N=52) 

25 

73 

50 

48 

2 

54 

4 


(1) Percentage of panelists indicating the type of implications as among the three 
that most significantly influenced the option chosen. 

(2) See Appendix 5 for a full description of the scenario. 

(3) "N" indicates the number of panelists who selected the option for a scenario. 


87 


Figure 6 

POLICY OPTION PANELISTS WOULD LEAST LIKE TO SEE IMPLEMENTED FOR THE FIVE ADVANCES 
CONSIDERED IN THE SECOND PEI, BY SUBJECT AND CATEGORY OF PANELIST (1) 



Actions of Psychopharmacological Agents Further 


Understood 


Promotion of research and implementation 

16 

12 

11 

12 

11 

62 

59% 

Control or limitation of research and 
implementation . 

8 

7 

14 

7 

7 

43 

41% 

Total 

24 

19 

25 

19 

18 

105 

100% 

Select-A-Boy , Select- A-Girl Marketable Kits 

Promotion of research and implementation 

18 

8 

15 

11 

11 

63 

60% 

Control or limitation of research and 
implementation 

7 

11 

10 

9 

7 

44* 

40% 

Total 

25 

19 

25 

20 

18 

107 

100% 

Amniocentesis Becomes Routine 

Promotion of research and implementation 

13 

11 

12 

8 

10 

54 

51% 

Control or limitation of research and 
implementation 

11 

8 

12 

12 

9 

52 

49% 

Total 

24 

19 

24 

20 

19 

106 

100% 

Environmental Causes of Disease and Trauma Further 
Controlled 

Promotion of research and implementation 

7 

9 

11 

2 

4 

33 

30% 

Control or limitation of research and 
implementation 

17 

10 

14 

18 

17 

76 

70% 

Total „ 

24 

19 

25 

20 

21 

109 

100% 

Computerized Medical Records in Use 

Promotion of research and implementation 

17 

8 

11 

9 

12 

57 

53% 

Control or limitation of research and 
implementation 

7 

11 

12 

11 

9 

50 

47% 

Total 

24 

19 

23 

20 

21 

107 

100% 


(1) 110 of 128 panelists (86%) completed the second PEI. 

(2) Self-assigned categorization. 

(3) See Appendix 5 for a full description of each advance. 

(4) Percentage of panelists who. responded to the item selecting the stated policy option. 


88 


Figure 7 

NEGATIVE CONSEQUENCES OF ADVANCES CONSIDERED IN THE SECOND PEI, BY LEAST LIKED 
POLICY OPTION 


Percentage of responses mentioning 


Advance (2) /Least liked 
Policy Option (3) 



Actions of psychophxrmacological 
agents further understood 


Promotion of research and 


implementation (N=61) 

3 

25 

11 

21 

16 

51 

66 

30 

0 

Control or limitation of research 
and implementation (N=43) 

16 

9 

4 

5 

2 

19 

49 

63 

0 

Select-a-boy 3 Select-a-girl 
marketable kits 










Promotion of research and 
implementation (N=62) 

6 

27 

8 

13 

5 

15 

84 

13 

2 

Control or limitation of research 
and implementation (N=44) ....... 

25 

52 

5 

14 

16 

11 

52 

16 

2 

Amniocentesis becomes routine 










Promotion of research and 
implementation (N=53) 

47 

47 

13 

15 

6 

17 

98 

15 

0 

Control or limitation of research 
and implementation (N=52) 

48 

15 

13 

23 

0 

2 

65 

40 

0 

Environmental -causes of disease and 
trauma further controlled 










Promotion of research and 
implementation (N=33) 

49 

12 

3 

21 

3 

42 

42 

49 

12 

Control or limitation of research 
and implementation (N=76) 

34 

3 

45 

5 

1 

12 

25 

46 

24 

Computerized medical records in use 










Promotion of research and 
implementation (N=57) 

11 

70 

11 

14 

4 

11 

42 

56 

2 

Control or limitation of research 
and implementation (N=50) 

22 

14 

10 

12 

4 

6 

12 

88 

2 


(1) Percentage of panelists selecting a policy option as that least liked who indicated 
the type of negative consequence among the three most significant negative consequences 
that would occur if the policy were implemented. 

(2) See Appendix 5 for a full description of each advance 

(3) "N" indicates the number of panelists who selected the policy option as that least 
liked. 


89 


Figure 8 

GROUPS PARTICULARLY AFFECTED BY THE NEGATIVE C ONSEQUENCES OF ADOPTING THE 
LEAST LIKED POLICY OPTION, PROMOTION OR LIMITATION OR CONTROL OF ADVANCES 
CONSIDERED IN THE SECOND PEI (1) 



Men 

. 10 

7 

30 

25 

9 

10 

0 

8 

0 

10 

Women 

. 13 

7 

65 

34 

59 

40 

0 

8 

12 

16 

Low-income people 

. 34 

19 

19 

32 

46 

48 

33 

40 

46 

32 

Children 

. 16 

7 

32 

9 

19 

27 

6 

17 

12 

8 

Young adults 


9 

27 

52 

13 

25 

12 

9 

7 

2 

Urban population 

8 

5 

0 

2 

0 

4 

27 

43 

0 

0 

Workers 


7 

0 

0 

15 

6 

12 

42 

9 

12 

Acutely ill people 

2 

19 

0 

0 

0 

0 

6 

4 

19 

30 

Chronically ill people .... 

. 16 

40 

3 

2 

11 

4 

12 

22 

39 

38 

Residents of health care 
institutions 


40 

0 

2 

9 

8 

6 

1 

21 

16 

Persons in prisons 

. 65 

30 

0 

0 

6 

0 

3 

0 

12 

2 

Physicians 


12 

6 

9 

9 

14 

3 

4 

37 

44 

Biomedical scientists 

8 

21 

0 

5 

2 

10 

0 

13 

9 

46 

Private industry 


2 

5 

9 

0 

2 

33 

13 

4 

6 


(1) Only groups mentioned by at least 25% of panelists for at least one policy option 
of at least one advance have been included in this figure. 


(2) See Appendix 5 for a full description of each advance. 

Research and implementation policy panelists would least like to see implemented. 
"N" indicates the number of panelists who selected the policy. 


( 3 ) 



91 


Chapter 3: 

Implications of Advances. 


93 


INTRODUCTION 

The preceding chapter presented summaries of the implications 
of advances by subject areas. This chapter addresses the impli- 
cations of advances more broadly, assessing the manner in which 
biomedical and behavioral advances in general will influence 
individuals and society. These implications of advances were 
derived from two sources. They were: 

* reports on panelists* responses to each advance and 
each scenario considered in the first PEI and each 
advance and scenario elaborated on in the second, 
provided by panelist reviewers; and 

* reports on the dimensions underlying the responses to 
all advances and all scenarios in the first PEI, and 
all advances in the second, provided by panelist 
reviewers . 

The implications of advances are discussed under three 
major headings: 

* Implications for individuals; 

* Implications for society; and 

* Moral and ethical issues. 

Individual implications relate to the potential impact of ad- 
vances on individual responsibility and choice, individual 
rights, and individual health. Social implications relate to 
economic effects, technological effects, social change, and 
minorities. Moral and ethical issues include the impact of 
advances on biological change, behavioral change, and equity. 


94 


IMPLICATIONS FOR INDIVIDUALS 

The panel’s concern for the individual was manifest throughout 
the implications of advances and policies. Responses focused 
on problems of individual health, effects on the individual's 
economic position, protection against stigmatization, the im- 
provement or protection of individual choice, the protection 
of individual rights, and other more specific issues. Both 
positive and negative effects on individuals were identified. 

In some advances the panelist's view of the individual 
appeared to be a critical factor in determining attitudes to- 
ward the advance, or toward policies designed to deal with the 
advance. What appeared to be critical was not so much the 
effect of advances on individual health or economics, but the 
potential effects on individual values or the relationship be- 
tween individual actions and social consequences. Thus, there 
was a tendency for individual effects to be confounded with 
either ethical or social considerations. 

The panel tended to favor the individual to the extent 
that it generally upheld individualistic values and supported 
the rights of individuals when these conflicted with the needs 
of society. However, there was a great range of opinion among 
panelists regarding where social concerns legitimately overrode 
individual concerns and where the exercise of individual rights 
might become detrimental to the social good. 


Individual 
Responsibility 
and Choice 


Panelists frequently looked at advances in terms of the way 
they would either increase or decrease personal responsibility. 


95 


particularly as this was manifest in the ability to exercise 

choice. As a panelist reviewer noted: 

It is an ideal for human life, accepted almost universally 
in our society, that a person take responsibility for his 
or her actions, develop the capacities required to act 
responsibly, and be held responsible by others. 

Advances in all of the areas had some qualities which could 
tend to enhance personal choice and responsibility, and they 
were almost always viewed favorably by panelists regardless of 
their overall position with respect to an advance. One pane- 
list reviewer suggested that the panel was divided into two 
groups holding quite different notions of personal choice and 
responsibility: 

One group appears to ground all aspects of the ethical 
dimension in a concept of freedom. Absolute freedom of 
choice is the most important ethical-moral source and 
norm, and any violation of it undercuts all ethical-moral 
aspects of life; therefore, freedom of choice is maxi- 
mized over against all other values. 

The other point of view is grounded in the belief that 
freedom of choice is indeed one of the most important 
ethical moral dimensions of life, but it is never in 
isolation and must always be exercised in relation to 
consequences. It is not an absolute value which stands 
of and by itself but only as a part of a complex of values 
from which it cannot be abstracted. The exercise of one's 
own freedom can only be done in relationship to the free- 
dom of others, and one cannot assume that the pursuit of 
one's own freedom will automatically in the long run bring 
the greatest good for oneself and others. 

Personal responsibility and choice are enhanced in two ways, 

either by the provision of information to an individual or by 

the creation of a new option. Sometimes both conditions were 

met in an advance. The exercise of personal responsibility and 

choice was seen as taking place within a social and political 

environment which has distinct and varying effects. While the 


96 


technologies themselves might have an inherent potential for 
increasing personal responsibility and choice, the interaction 
of these technologies with the individual, society, the govern- 
ment, or various agencies could lead to decrements rather than 
increments in personal responsibility and choice. 

Panelists regarded advances in information technology as 
opening the possibility for diminishing the information received, 
Computers could be programmed incorrectly or misinformation 
entered leading to false information on which an individual 
might act. Physicians, particularly those who might themselves 
be opposed to procedures like abortion, could withhold informa- 
tion, or testing could produce false positive or false negative 
results. Some panelists believed that the nature of the tech- 
nology itself would deter some people from its use. Due to a 
lack of sophistication, poor and minority groups, for instance, 
were considered by some panelists unlikely to be able to deal 
with mechanistic advances, such as computer technology. There 
were also concerns about differential applications of technology 
This was usually characterized as taking place along economic, 
racial, or ethnic lines. Thus, the poor may not have access to 
amniocentesis and the information it provides. Alternatively, 
the poor could be offered an "excess" of information about 
sterilization procedures. 

Individuals can also receive information they do not want, 
a particular danger in widespread screening programs. A person 
opposed to abortion or unsure about abortion could be inadver- 
tently included in a screening program and provided information 


97 


about fetal defects. Under these circumstances individual 
choice or responsibility would not be enhanced, but conflict 
and guilt might arise instead. 

If options are foreclosed, or made less viable in some way, 
personal responsibility is derogated. There was particular con- 
cern about the possibility of government intervention in the 
subject areas Systematic Control of Behavior 3 Reproductive Engi- 
neering 3 and Genetic Screening . The government could force the 
population (or selected parts of it) to take behavior control 
drugs, manipulate the sex ratio through sex selection technology, 
or affect the genetic future by mandating screening and selec- 
tion procedures. Intervention could be insidious, rather than 
direct. Welfare payments might be made contingent upon sterili- 
zation, payment for amniocentesis might be made contingent upon 
aborting any fetus identified as defective, or amniocentesis 
itself might be promoted through the expedient of refusing pub- 
lic support to defective children. 

Social values could develop which would tend to foreclose 
individual options. This seemed a particularly strongly held 
view in the subject areas Reproductive E'ngineering and Genetic 
Screening . There was some concern that the freedom of choice 
to undergo amniocentesis would be abrogated by social pressures 
to prevent the birth of "defectives". Some panelists also saw 
social attitudes as having an effect on the acceptance of behav- 
ior modifying drugs as a way of coping with pressures. 

Agents and institutions of various kinds were considered to 


exert a coercive effect on individuals. The institutional set- 


98 


ting itself (prisons or hospitals) may be intrinsically coer- 
cive since cooperation with a suggested option (particular ther- 
apy) is rewarded. Schools or teachers could exert a coercive 
effect on children in the imposition of such advances as anti- 
anxiety tapes since children may not be able to exercise a tru- 
ly informed choice. Similarly, patients suffering a mental 
problem of some kind may not be able to exercise a responsible 
choice in decisions about the administration of drugs or sur- 
gery. 

It was not only patients, or those to whom the advances 
would be administered who might suffer coercion. Physicians 
were sometimes seen as having their options foreclosed by pres- 
sures to conform. The use of life extending technologies was 
viewed as mandated by threats of malpractice, as was the use of 
screening technologies. 

Individual The rights of individuals were proclaimed throughout the re- 

Rights 

sponses in all of the subject areas. Among these rights were 
noted: the right to life, the right to procreate, the right to 

privacy, the right to psychological and physical health, the 
rights of women, the rights of minorities, the right to treat- 
ment, the right to freedom of choice, and the right to avoid 
coercion. For the most part, ’’rights" were simply asserted, 
their existence apparently considered self-evident, and only a 
few were accorded an evidentiary basis in law or the Constitu- 
tion. 

Some of the rights asserted were manifestly affected by 
the technological advances forwarded in the study, or reflected 


99 


in an understanding of the present state of technology. The 
right to die, for instance, has been asserted largely as a 
function of relatively recent developments in life saving medi- 
cal technologies. The right to procreate was seen as being 
given new meaning by potential advances in reproductive engi- 
neering; sometimes that meaning was unfavorable, as in surrogate 
mothering. The right to select the sex of one's offspring was 
advanced as a function of developments in sex selection technol- 
ogy. 

Individual rights appeared almost sacrosanct to a number 
of panelists, but for most there was an apparent willingness 
to trade off rights in some areas, or to forego putting them 
into effect in others. For instance, there was some sentiment 
for trading off individual rights to refuse behavior control in 
the interest of social stability, though many panelists strong- 
ly upheld individual rights in this regard. There was also a 
sense that some individual rights would be foregone in defer- 
ence to the overall health needs of society, particularly in 
matters of environmental health and safety. However, there was 
a distinct sense here that things could go too far in the dero- 
gation of individual rights. Seat belts and motorcycle helmet 
laws were offered by several panelists as examples of unwarrant- 
ed governmental intervention in private lives. Some rights 
might not be exercised in the interest of social welfare or 
family harmony. Exercise of an individual right to select the 
sex of children might affect the sex ratio, to the detriment 
of society, or create a clash between family members over the 


100 


Individual 

Health 


sex to be selected. 

The loss of individual rights was a primary concern to 
some panelists. In general, technologies which could be applied 
on a widespread basis were seen as potentially threatening to 
individual rights. In one area. Computerized Medical Records In 
Use 3 the threat to individual rights formed the central theme 
of panelists opposed to the technology. The critical question 
about the loss of individual rights seemed to center on whether 
they were freely given or expropriated by another individual, 
an agency, or the government. Panelists countenanced the indi- 
vidual’s relinquishing of rights in situations of informed con- 
sent and objected strongly to curtailment of rights by external 
agents or agencies when consent was not solicited or received. 

Panelists seemed in general agreement that advances would have 
an overall beneficial effect on individual health. They also 
seemed to agree on the possibility of some risks to individual 
health arising from the advances. They differed considerably 
on the degree of risk foreseen or acceptable. Few panelists 
adopted either a "damn the torpedoes" outlook or called for a 
ban on technology based on the risks. Almost all panelists were 
willing to accept some level of risk. 

For some types of advances the individual health issue 
centered on the possibility of iatrogenic disease — through 
such things as errors in the medical record, errors in testing 
procedures producing false positives or false negatives, and 
errors in surgical procedures. Where these possibilities 
existed, panelists were divided over the relative benefits 


101 


and harms with some preferring to avoid the potential risk, 
while others appeared to consider such a risk acceptable. Ad- 
vances may also affect the health of individuals of different 
social classes differently, because of something inherent either 
in the technology (requiring technical sophistication) or in 
an aspect of society itself (race or class attitudes). In these 
cases some panelists were either willing to accept some risk of 
inequity or contended that the same classes would be differen- 
tially affected by the absence of technology. Other panelists 
seemed unwilling to accept the risk, particularly when inequity 
seemed inherent in the technology, rather than as a function of 
social attitudes. 

Several advances raised the fear of unknown effects on 
individual health. A lack of longitudinal data concerned those 
who feared that obvious short-run benefits would prove seduc- 
tive when too little was known about long-term consequences. 


102 


IMPLICATIONS FOR SOCIETY 

Social concerns and issues were more frequently commented on 
than any other type of implications. Where social effects 
were seen they were frequently complex and productive of con- 
siderable conflict. In Systematic Control of Behavior 3 for 
example, benefits such as increased productivity, lowered costs 
of curbing social deviance, and profits for private enterprise 
were ranged against such costs as the curtailment of individual 
rights, and the notion that behavioral treatments might become 
the only acceptable means for controlling social problems. 
Similar problems were suggested for Genetic Screening where the 
fear expressed was that society’s desire to decrease the number 
of defectives born (for cost and other reasons) might lead to 
a social climate in which pressures would be exerted to force 
screening. A concomitant loss of social willingness to provide 
support for defectives who slipped through the screening pro- 
cess was also feared. 

Panelists foresaw dangers in implementing advances that 
might lead to the abuse of minority groups, or the undermining 
of traditional social values, in such areas as: the family, 

freedom, political order, religious groups, professions, equal- 
ity under the law, the sacredness of human life, and protection 
of the weak (including fetuses). 

Panelists' responses to the implications of the advances 
revealed four major areas of concern: technological effects, 

economic effects, social change, and effects on minorities. 


103 


Technological Technological benefits expected from advances included such 
Effects 

things as increased knowledge, improved health care, and con- 
tributions to future research. In general it appeared that new 
knowledge was of greatest importance to panelists as a benefit, 
and was frequently cited by those in favor of promoting research 
and implementation of advances. Not all technological effects 
were considered beneficial, however, and some panelists thought 
there were inherent dangers in technology which could operate 
to reduce or even negate the benefits. 

Panelists who saw technological benefits argued that re- 
search is cumulative and that blocking technological develop- 
ment harms those for whom the technology is being developed, 
creates a climate inimical to research in general as an atti- 
tude of control spreads to other areas, and stalls progress in 
the accumulation of human knowledge. Panelists who saw dangers 
in technological advance did not necessarily disagree that bene- 
fits would be forthcoming but felt that the benefits would not 
be achieved without careful control. These panelists suggested 
that technology was being pushed faster than controls could be 
devised to handle it and that this resulted in the application 
of technologies which were flawed in one way or another. There 
was also a notion that technological development could be mis- 
directed — a technology once developed and applied tends to 
block off other, perhaps better technologies (e.g., improving 
cures for cancer might lessen efforts to find ways of preventing 
cancer) . 

A panelist reviewer concluded from this dichotomy: 


104 


One group seems to have an implicit faith in the inher- 
ent power of a freewheeling approach to produce the 
greatest good for the greatest number at the least cost 
for the whole of society through the automatic working 
of its search for freedom. 

The other group works much more out of a checks and 
balance point of view which argues that the largely 
unchecked and all out promotion of advances could prove 
to be more expensive, more dangerous, less equitable, 
and in the long run more destructive to the total 
values, economic, political, and legal structures of our 
society. 

General improvements in health care were expected from a 
number of advances. The discussion of computerized medical 
records exemplified some of the beneficial attributes foreseen. 
According to a panelist reviewer, panelists suggested the 
technology would result in: 

Stemming the rapid rise of cost of medical care; increased 
opportunity for preventive health care by identifying 
and/or treating high risk individuals or groups; standardi- 
zation of health care; easier ascertainment of substandard 
care and elimination of incompetents (quality control)... 

But there could be problems in attempting to improve health care 
without some "checks and balances" as panelists contended in 
discussing amniocentesis. Here there was concern that develop- 
ment of a widespread program would result in increased demand 
for competent personnel to undertake the procedure. In the 
absence of a means to fulfill this demand it was considered 
likely that there would be a greater use of personnel with a 
lower level of training, thus increasing the potential for 
iatrogenic disease. 

The production of new knowledge and contributions to future 
research were generally considered beneficial, but some draw- 
backs were identified. Advances in Systematic Control of Behav- 


105 


ior 3 Genetic Screening 3 and Data 3anks 3 Computer Technology 

were all noted for the potential to produce new knowledge funda- 
mental for future research. Computerized medical records, in 
particular, were regarded for their potential to usher in a 
new era of epidemiological research and discovery. Genetic 
screening would provide data for genetic research. Psychopharm- 
acological agents and psychosurgical procedures were seen as 
contributing to an understanding of the human mind. 

These benefits were countered by a variety of concerns. 
Errors in the record might negate the benefits of computer tech- 
nology. The risks entailed in gathering knowledge about genetic 
engineering might not be worth the benefits. Advances in know- 
ledge about the relationships between health and environment 
could result in severe industrial or geographical dislocations 
as people moved from dangerous industries or areas to less 
dangerous ones. 

Economic The economic concerns which stood out in panelists' responses 

Effects 

included the relationship between the costs and benefits of 
research, and the costs of bureaucratic supervision. Some ad- 
vances seemed to generate agreement among panelists regarding 
the relationship between costs and benefits. This occurred 
mainly in areas where high cost technologies were associated 
with limited distribution, as in the case of the Compact 3 W ear- 
able 3 Artificial Kidney. Panelists generally did not favor ad- 
vances of this nature. The line between where a technology 
became cost-effective seemed very thin, however, and panelists 
disagreed extensively over whether costs of development or the 


106 


costs of the attendant bureaucracy would overwhelm the benefits. 

Advances involving widespread application or availability 
most frequently raised concerns about the costs of bureaucratic 
supervision. Costly maintenance systems were foreseen for 
screening programs, environmental health and safety initiatives, 
and medical records systems, and there was no agreement over 
whether these costs would be greater or less than the expected 
benefits. This problem was exacerbated by the perceived lack 
of any kind of accounting procedures which might consider social 
costs and benefits as well as financial profit and loss. 

A variety of other economic effects were touched on in 
the discussions. Life extending technologies could increase 
the costs to society of sustaining life, and environmental reg- 
ulations could cause major population shifts. The relationship 
between economics and social values was also explored by some 
panelists who were concerned that wholesale use of behavior 
control methods might have an undesirable effect on economic 
productivity by affecting the work ethic (but not all panelists 
viewed this eventuality as a societal harm). 

On the positive side, a number of advances were seen as 
reducing the costs of health care for both the individual and 
society. Screening technologies and behavior control were con- 
sidered likely to reduce the costs of custodial care in insti- 
tutions, and computer technology was considered likely to re- 
duce the costs of individual health care. Benefits were even 
noted for the world economic picture stemming from developments 
in reproductive control which would help the world population 


107 


Societal 

Change 


problem. 

Though society was viewed by the Consultant Panel as open to 
change, certain social patterns were related to values so funda- 
mental as to warrant overriding protection. The sex ratio (viewed 
in some contexts as a fundamental social pattern, but in others 
as a "natural order") and monogamous marriage were considered 
such patterns. The * technology of sex selection was commonly 
agreed to have a potential for changing this social pattern. 

The majority of panelists thought (and the public concurred) 
that the direction of this potential change would be for a pre- 
dominance of male children — particularly among first borns. 

Some panelists felt that no significant change would take 
place, or, if it did, countervailing forces, inherent in society 
or deliberately set into motion, would tend to smooth out dif- 
ferences over time. A larger number felt that a preference 
for male children would be persistent and that a great imbalance 
in the sex ratio would lead to other social changes like in- 
creased homosexuality or polygamous marriage. 

Other changes in fundamental social patterns were noted 
but not stated so unequivocally. Behavior control technology 
could influence the relationship between governing and governed; 
screening technologies could lead to notions of genetic equality 
as an obtainable social end. All of the technologies noted 
were seen by at least some panelists as having an impact on 
religious or moral beliefs widely held in western society. 


108 


Minorities 


Concern for minorities cut across most of the advances and 
subject areas. This concern tended to take two forms: either 

minority groups could have an advance forced on them to their 
detriment, or they could be denied access to the advance on a 
par with the more advantaged. 

Generally, the panel did not point to particular ethnic 
or racial groups but aggregated these groups as, simply, "minor- 
ities". The issue arose in the context of those advances where 
some sort of discrimination, labeling, or manipulation could be 
applied by a relatively powerful force, e.g., the government, 
the wealthy, or society at large, to the disadvantage of others, 
e.g., the poor, the institutionalized, or the uneducated. Pan- 
elists least liking promotion of an advance frequently high- 
lighted possible dangers of social control over minorities and 
the poor as an outcome of its promition. Amniocentesis, for in- 
stance, was considered an area where social policy could oper- 
ate against those resisting the procedure. Roman Catholics were 
used as an example of a group which might refuse amniocentesis 
on religious grounds, and suffer subsequently from pressures 
exerted by those in the majority. However, panelists opposed 
to control were apt to foresee another kind of discrimination. 
Some feared that only the sophisticated and the wealthy would 
be able to avail themselves of amniocentesis if it were not 
widely distributed, thus discriminating against the poor and 
less well educated. 

It seemed implicit in panelists' arguments that trade-offs 
might have to be considered among various minority groups. By 


109 


promoting an advance, the rights of one group might be threat- 
ened; by controlling or prohibiting the advance, another group, 
or even the same group, could be negatively affected in some 
other way. 


110 


MORAL AND ETHICAL ISSUES 

Panelists addressed moral and ethical issues extensively. In 
many cases these issues were entwined with individual and 
social questions — as in the discussions of individual rights 
or the treatment of minorities — and these have already been 
presented. The broad moral and ethical issues considered by 
the panel related to the potential for fundamental changes in 
human biology and behavior, and the question of equity or 
social justice. 

Biological Advances in gene therapy, amniocentesis, screening for inborn 

Change 

errors of metabolism, and sex selection all raised similar 
issues with respect to altering basic human biology. Gene 
therapy could become an instrument for introducing completely 
new germ plasm to the gene pool of the species, or the manipula- 
tion of genes at some locus could have the unanticipated side 
effect of altering genes at other loci. The result in either 
event would be alterations in human biology of a completely 
unknown type and direction. Gene therapy was nearly univer- 
sally feared because of the uncertainties involved in assessing 
the long term outcomes, though there was some support for pro- 
moting its development for short-term gains. 

Amniocentesis and screening techniques in general were 
seen as allowing a directive effect over human biological char- 
acteristics. The direction would come about through a process 
of negative eugenics as "defectives" were identified and thera- 
peutic abortion took place. Screening techniques in particular 
could have a sort of genetic "leveling" effect, bringing a 


Ill 


rather new and different meaning to the notion that "all men 
are created equal". 

Many panelists also tended to see screening technologies as 
part of a general social effort to produce healthy children, 
arguing that "screening will enable us to create a new generation 
of biologically less imperfect children." Those opposed to 
screening, or at least suspicious of it, feared that the process 
of selection would transcend a search for normality and become 
a striving for perfection. 

Sex selection technologies could have a limited impact on 
biological change if the technology was used for genetic rea- 
sons — the avoidance of sex-linked diseases. The magnitude of 
the impact was somewhat obscured since the technology, it was 
recognized, would allow expression of characteristics to be 
avoided, while at the same time allowing continuation of the 
genes in the gene pool. Panelists were also concerned that once 
a sex selection capability had been introduced, demand for the 
ability to select other characteristics would follow. 

The potential for biological change noted above was widely 
agreed upon by the panelists. However, there was substantial 
disagreement about whether or not changes would be beneficial 
or harmful, or in the case of undeniably harmful changes whether 
or not they would come about at all. Panelists were very much 
divided — either on ethical grounds, or on the grounds of indi- 
vidual rights versus social responsibility — on whether there 
was a human right or duty to engage in willful manipulation of 
the genetic heritage of the species. 


112 


Behavioral 

Change 


Equity 


There was no doubt among panelists that human behaviors could 

be changed. A panelist reviewer identified a division between 

a "holistic" view of humanity and a mechanistic view. Panelists 

adopting a holistic perspective were concerned about advances in 

Systematic Control of Behavior because of a perceived potential 

for very fundamental changes in a Western, humanistic view of 

man as a creature of free will and personal responsibility. The 

use of drugs, psychosurgery, and even techniques such as tension 

reduction, was viewed as promoting a dulling effect on society 

as people became homogenized in accordance with some central 

set of approved behaviors. As a panelist reviewer noted: 

Among the dangers feared, the conception of a person as 
ready for manipulation was very prominent.... It was 
alleged to be difficult to square the conception of mani- 
pulability with the conception of responsibility.... 

There was also considerable discussion about the ideals 
appropriate to human life and h ow behavior control ad- 
vances may trim those ideals unnecessarily. 

Panelists' views on these changes were mixed. In general it 
appeared that so long as the effects were confined to the re- 
habilitation of individuals needing assistance to cope with life 
or to return to society as productive members, they were generally 
viewed favorably. The advances were viewed much less favorably 
in connection with their application to classes of individuals, 
or if they were deliberately sought as a means of avoiding per- 
sonal responsibility. 

The concern for equity, or social justice, was expressed through- 
out the discussion of advances and was particularly prominent 
in discussions of scenarios. The notion that policies should 
be fair to various interest and identity groups encompassed 


113 


fair treatment for the poor, prisoners, patients, physicians, 
women, and virtually any other group identified in the discus- 
sions. Underlying the discussion of equity was the implicit 
sense that a pluralistic society could only be maintained in a 
climate amenable to a plurality of values. This point was 
explicitly made in connection with behavior control technologies, 
and was prominent in the discussion of amniocentesis. 

One aspect of the question of equity was the notion of equal 
access to health care. Concern over equal access was reflected 
in a number of advances and related to the fair distribution of 
the benefits of technology (or sometimes the equitable distribu- 
tion of risks). Panelists were very concerned about equal access 
to high cost technologies even to the extent of questioning 
whether it was appropriate to spend public funds on technologies 
which might have limited distribution. A particular concern 
in limiting access to scarce technological resources was the 
avoidance of "factoring of social standing or social worth into 
the decision [about who should benefit from the technology]", 
according to one panelist reviewer. With regard to technolo- 
gies of wide application, panelists voiced concern about either 
social attitudes, personal values, or even the technological 
nature of an advance itself and the role these factors might 


play in equal access . 



115 


Chapter 4: 
Policies. 



117 


INTRODUCTION 


The implications of policies to control and regulate biomedical 
and behavioral research and the implementation of resultant 
technologies were identified using a four step process: 

* Policies to deal with specific advances in biomedical 
and behavioral research and technology were identified 
in the First Policy Evaluation Instrument (PEI), and 
used to construct a series of general policy state- 
ments for consideration in the second; 

* Policy approaches were identified from panelists’ 
evaluations of the general policy statements and 
from panelists’ elaborations on those policy state- 
ments considered most urgent, and used to construct 
four policy scenarios for evaluation in the third 
PEI; 

* Consequences of and barriers to implementing the 
national policy described in the four policy scenarios 
contained in the third PEI were identified, and amend- 
ments and additions to the policies that comprised the 
scenarios described; and 

Panelist responses to the third PEI were summarized and 
analyzed to produce a compendium of implications for 
each of the policy scenarios. 

These four steps are outlined below; the results of the 
process are described in the remainder of this chapter. A 
detailed description of study methods is provided in Appendix 1. 


Policies 
for 

Specific 
Advances 

of the five subject areas considered. In addition, panelists 
were asked to suggest the kinds of policies which would help 
in the resolution of the issues raised in the six scenarios 
described . 

Panelists' responses to each advance and scenario were 


In the first PEI, panelists were asked to select and describe 
the research and implementation policies most appropriate to 
deal with the advance they considered most important for each 


118 


General 

Policy 

Statements 


analyzed and summarized by project staff. A list of general 
policy statements was compiled from these results; a review of 
the legislative intent in setting up the Commission, the man- 
date for the study; and from various documents produced by the 
Commission itself. The initial list of statements was reviewed 
by the Study Design and Management Group (SDMG), and the final 
list of policy statements selected. 

In the second PEI panelists were presented with 23 general policy 
statements (and their associated sets of subsidiary statements) 
and asked to decide whether or not they agreed with the state- 
ment and whether or not it was urgent to implement the policy. 
They were then asked to choose the five most urgent policies, 
to rank them in order of urgency, and finally, to elaborate 
on the three policies selected as most urgent to implement. 

Panelists’ responses to each general policy statement, 
and their elaborations on those policies considered to be most 
urgent, were analyzed and summarized by project staff. These 
summaries were sent to panelist reviewers to identify and sum- 
marize the dimensions underlying panelists’ responses. 

Panelists' elaborations on those general policies viewed 
favorably were used to construct four policy scenarios. Each 
scenario dealt with a separate aspect of a possible national 
policy; collectively they described a comprehensive national 
policy. Elaborations on the general policy statements formed 
elements of the policy scenarios; where necessary, elements were 
added to round out the policy. The addition of elements was 
made in line with the general direction suggested by panelists' 


119 


Policy 

Scenarios 


elaborations on the general policy statements. 

The policy scenarios were reviewed by members of the SDMG 
and the same panelist reviewers who had reviewed the summaries 
of the general policy statements, and revised in line with their 
suggestions. The revised policy scenarios were then carried 
forward into the third PEI. 

In the third PEI, panelists were asked to examine the four policy 
scenarios that collectively described a possible national policy 
with respect to biomedical and behavioral research and technology. 
Each scenario consisted of a number of particular policy state- 
ments, elements of the national policy. The four policy scenar- 
ios were: Permanent National Commission; Public involvement 

in policy decision-making; Biomedical and behavioral research; 
and Implementation of biomedical and behavioral technologies. 

A synopsis of the four policy scenarios is shown in Figure 9. 

They are described fully in Appendix 6. 

For each scenario, panelists were asked to: 

* identify and elaborate on positive and negative con- 
sequences they anticipated would result if the policy 
were implemented; 

* identify and describe barriers to implementation of 
the policy and the ways in which these barriers might 
be overcome; 

* indicate their degree of support for, or opposition 
to, each of the particular policies that comprised the 
scenario ; 

* offer specific amendments to particular policies 

that would enhance positive consequences or ameliorate 
negative ones; and 

* add additional policies they thought necessary to com- 
plete or augment the national policy described. 


120 


Identification 

of 

Implications 


Panelists were also asked to indicate their preferred alloca- 
tions for health and health research and development (R&D) vis- 
a-vis other activities, and the relative priorities that should 
be afforded to the different types of R&D activities described. 

For analytic purposes, panelists were classified on the basis 
of their mean scores as supporters or opposers of a policy scen- 
ario. Responses to each policy scenario were sorted by this 
mean score and summarized by project staff. These summaries 
were sent to panelist reviewers to identify the dimensions under- 
lying panelists’ responses. These dimensions were then analyzed 
to identify common themes. Resource allocation items were 
analyzed statistically. The statistical analyses, materials 
provided by panelist reviewers, the original summaries, and 
individual panelists’ responses were used as resources for writ- 
ing this and the subsequent chapter of the reporu. 

Figure 10 presents the degree of support for implementing 
each of the four policy scenarios based on a mean score of re- 
sponses to the particular policies. Figures 11 to 14 present 
panelists’ votes on each particular policy contained in the 
policy scenarios. The remainder of this chapter summarizes 
the findings for each of the four policy scenarios and for the 
resource allocation questions. Each set of findings is followed 
by a brief analysis and evaluation. The next chapter examines 
the implications of these policies with respect to: the need 

for controls; the role of government; justice; economic facotrs; 
and public participation. 


121 


PERMANENT NATIONAL COMMISSION 

The first policy scenario described a Permanent National Commis- 
sion on Biomedical and Behavioral Research and Technology estab- 
lished by an Act of Congress. Particular policies addressed or- 
ganization of the Commission, membership, staffing, level of 
authority, scope, accountability, and evaluation of the Commis- 
sion's performance. The Commission was described as having a 
national level of authority which included promulgation of poli- 
cies and guidelines, the establishment of a national strategy for 
public funding of research, and the auditing of research projects. 

Findings Support for the concept of the Commission was relatively high. 

Supporters of the policy represented 54% of the panel, and only 
17% were opposed — the smallest number opposed to any of the 
policy scenarios in the study (Figure 10). Consistent support 
was received across all categories of panelist except medical 
scientists. Ethicists offered support in the greatest measure 
(64%); medical scientists least (33%). The first policy statement 
in the scenario, essentially a vote on the establishment of the 
Commission itself, received the strong support of 51% of the 
panel and an additional 26% offered approval if the policy were 
amended in some way. Only 11% of the panel either opposed the 
policy statement in any form or found it unnecessary (Figure 11, 
policy no. 1). 

Panelists were generally in favor of those aspects of the 
policy scenario which involved the Commission in a public communi- 
cations process. Policies involving dissemination of information 
about the Commission's policies, evaluations of its efforts, re- 


122 


suits of the audits of research, or interface with the public 
and interest groups in the development of policy were strongly 
supported by as many as 82% of the panelists (Figure 11, policy 
nos. 9, 13, 14, 18, and 19). Policies which related to the Com- 
mission’s jurisdiction and authority did not fare so well. The 
purpose of the Commission drew strong support from only 32% of 
the panel and qualified support from an additional 29% (Figure 11, 
policy no. 2). A majority of the panel opposed the way in which 
the Commission allocated research funds (Figure 11, policy no. 11) 

In general the policy amendments offered were directed to- 
ward either administrative arrangements (modifications of speci- 
fic points such as number of Commissioners , term of service, etc.) 
or toward changes in the scope or level of authority of the Com- 
mission, In the latter case the predominant direction of change 
was to reduce the Commission’ s scope. 

Three major dimensions were identified in panelists' re- 
sponses. They were: 

* Economic concerns; 

* Quality of research; and 

* Use or abuse of power. 

Economic concerns . Economics formed a central theme in 
the responses of a number of panelists whether for or against 
the Commission. To some, the current costs of research and medi- 
cal care served as justification for the establishment of a 
Commission which might serve to ensure a just distribution of 
funds appropriate to a national system of priorities and goals. 

To others, the Commission represented the intrusion of a stag- 


123 


gering bureaucracy which would enormously increase the costs of 
biomedical and behavioral research. 

Quality of research . The quality of research was exten- 
sively addressed. Favorable aspects of the scenario Commission 
included benefits for research quality, efficiency, and effec- 
tiveness. Duplication of effort would be avoided; wasteful, 
harmful, or dangerous research would be weeded out; and a 

haphazard approach to the awarding of research endeavors 
would be supplanted by a goal-directed effort which, as 
commerce has shown, would inevitably lead to a more 
rapid resolution of pressing health needs of our people. 

Moreover, researchers would become accountable — finally 

— to a series of overseers, who would ensure that all 
research was performed in an ethical fashion, scientifi- 
cally sound, and pursued in a manner in accord with the 
original protocol, and that some demonstrable benefit 
might be expected; for if these criteria were not met, 
the already funded project would be swiftly discontinued. 

Ill effects of the Commission were also described. Some 

panelists viewed the composition of the Commission as politically 

motivated and lacking scientific vision. The short term of office 

for Commissioners (three years) would preclude attracting truly 

outstanding candidates. The massive increase in red tape and 

paperwork, and uncertainties of finding grant support were thought 

to be so intolerable that it would repel our finest scientific 

minds. All of this would lead to a significant deterioration 

in the quality of biomedical research. Finally, as one panelist 

reviewer observed: 

...Opponents of the Commission saw the allocation of 90% 
of the funds to priority projects [stated in the scenario] 
as catastrophic, and they based their view on the fact 
that most clinically significant advances have been the 
result of serendipitous discoveries emanating from the 
basic sciences. 


124 


Analysis 

and 

Evaluation 


Use or abuse of power . The use or abuse of power was ex- 
tensively addressed, with some panelists alluding to the power 
of the pharmaceutical companies, medical researchers and the 
medical establishment in general as justification for establish- 
ing a Commission. Opponents of the Commission protested against 
the politicization of research, the usurpation of Congressional 
powers, and the loss of checks and balances in the democratic 
system, seeing the Commission itself as an abuse of power. In 
terms of its scope, some questioned its legality under the Con- 
stitution. 

A majority of panelists supported the concept of a Permanent 
National Commission as a means of dealing with the problem of 
directing and regulating biomedical and behavioral research and 
technology. Opposition to the concept arose over questions of 
cost and the possible harm to the research effort growing out of 
an increased bureaucratization of research. The underlying ques- 
tion of whether the individual freedom of researchers "to pur- 
sue their interests in a climate of freedom", in the words of one 
panelist reviewer, should be "subservient to the public will 
and needs", was resolved by most panelists in favor of the public 


need. 


125 


PUBLIC INVOLVEMENT IN POLICY DECISION-MAKING 

The second policy scenario dealt with public involvement in 
policy decision-making. The scenario described provisions of 
the Act designed to encourage public involvement and the dissem- 
ination of information to the public. Particular policies 
addressed the Commission's responsibilities with respect to pub- 
lic participation, the gathering of public opinion, and the 
means and standards for dissemination of information. The poli- 
cies also specified the creation of five federally funded re- 
gional information centers to support the involvement and dis- 
semination efforts. 

Findings Overall this was the least supported of any of the policy scen- 

arios. Some 44% of the panel generally supported the policy, 
but 40% were opposed (Figure 10). The greatest level of support 
was found among representatives of the public interest (65% sup- 
ported) and the heaviest opposition among medical scientists 
(58% opposed). The first policy statement in the scenario — 
another measure of the panel’s overall view — was supported 
as written by 44% of the panelists and approved if amended by 
another 26% (Figure 12, policy no. 1). 

The panel appeared to be generally in favor of the ends 
of the scenario, but unhappy with some of the means . The parti- 
cular policies which stated the ends of public participation in 
policy formation, public education, and dissemination were gen- 
erally well received, sometimes by over 75% of the panel (Figure 
12, policy nos. 2, 3, and 4). Some means were also approved — 
such as public meetings and information dissemination through 


126 


established media. However, any aspect of the policy scenario 
which touched upon the existence of the five regional informa- 
tion centers was strongly opposed, and no policy which mentioned 
the centers was supported by a majority of the panelists. The 
particular policy establishing the five centers was approved as 
written by only 19% of the panelists and the policy on appro- 
priations by 26% (Figure 12, policy nos. 7 and 10). Opposition 
centered on the exclusion of existing agencies (such as univer- 
sities) from consideration as centers, and the cost involved. 

The amendments, therefore, buttressed the view that costs and the 
opposition of established institutions would be major negative 
consequences of the policy. 

Two major dimensions were identified in the panelists' 
responses to this scenario. They were: 

* Views of the public; and 

* The value of information centers. 

Views of the public . Whatever the context under discussion 
— the anticipated effects on the quality of research, the 
social dimensions of public participation in policy formation, 
public education and the dissemination of information being the 
main points — outcomes, as noted by a panelist reviewer, seemed 
to be based on one of three views of the public: 

* A public interested in [biomedical and behavioral 
technology], seeking information, and with a reser- 
voir of ideas for technological problem-solving and 
with well-grounded reservations about present tech- 
nological solutions. 

* A public primarily interested in other things, and 
largely disinterested and uninformed about the de- 
tails and issues involved in [biomedical and behav- 
ioral technology]. 


127 


* A public consisting of self-selected individuals and 
interest groups which might have either a positive 
or negative impact. 

Supporters of increased public involvement occasionally went be- 
yond accountability and consumer protection to a populist sense 
of participation as the public's natural right (as the eventual 
owners of all social institutions). Those opposed sometimes 
adopted an elitist tone. 

Positive consequences were anticipated when an intelligent 
and informed public is involved. The public enters into a produc- 
tive and valuable partnership with the scientific community; di- 
versity is encouraged without reducing productivity; more support 
is obtained for research activities and for the application of 
the developed technologies; research becomes more comprehensive; 
and other specialists (via the mechanism described for public 
participation) participate in the research process. Research is 
also likely to be improved by open, intelligent debate (involving 
the public) leading to priority setting and policy making, and 
there may be increased scholarly attention to research policy 
as a field of study. 

Negative consequences were anticipated from a disinterested 
public. Rather than open debate, panelists feared acrimony and 
the possibility that demagogic attacks would stir public fears 
about research. In these circumstances direct participation could 
lead to the curtailment of research, or encouragement of only 
the most pedestrian of projects. 

The value of information centers . While the concept of pub- 
lic participation seemed reasonably palatable to most panelists. 


128 


Analysis 

and 

Evaluation 


though a cause for uneasiness to some, the provisions for the 
information centers were less well liked. Mention of these cen- 
ters was infrequent in the positive consequences. They were con- 
sidered potentially valuable as a public resource supplying more 
detailed and accurate information on biomedical and behavioral 
research and technology and the investment of public funds than 
might be available through the media. They were also valued for 
the potential to increase public confidence in research and re- 
searchers, for their use as a forum, and as a decentralized count- 
erweight to the Commission. 

Among the negative consequences, the centers were prominent- 
ly mentioned in connection with economic and technical factors. 
Panelists expressed concern over costs and the ability of the 
centers to carry out neutral studies on sophisticated projects. 
Cost of the centers was a frequently mentioned barrier to im- 
plementing the policy scenario and there was a strong feeling 
that established institutions would oppose their development. 

There was also a fear that the centers could become a "boon- 
doggle" providing only the illusion of public participation. 

The sum of the responses to this policy scenario seem to approve, 
in principle, the notion of public participation and public educa- 
tion. However, the positive benefits expected from improved pub- 
lic participation and education were intangible, having to do 
with an improved climate for research and decision-making rather 
than providing direct contribution to the outcome of research. 
Under these circumstances, panelists seemed loath to approve ex- 
tensive funding, or new departures which ran the risk of challeng- 
ing existing institutions or agencies. 


129 


BIOMEDICAL AND BEHAVIORAL RESEARCH 

The third scenario described the Commission's jurisdiction over 
biomedical and behavioral research. Particular policies out- 
lined the scope of Commission authority, specified policies with 
respect to the review of research proposals, and described the 
establishment and organization of Regional Review Boards and 
Institutional Review Boards, and described the creation of a 
compensation fund for subjects of research. Policies dealing 
with the review boards described responsibilities, membership, 
staffing, appeals processes, and evaluation. 

Findings This policy scenario received more support than any other. On 

the whole, 63% of all panelists supported the policy while only 
22% were opposed (Figure 10). Representatives of the public 
interest and ethicists were most frequently in support (83% 
and 79% respectively) while medical scientists and social scien- 
tists supported the scenario less frequently (46% and 50% re- 
spectively). The first policy statement in the scenario which 
established the Corrmission' s jurisdiction over biomedical and 
behavioral research was supported as written by 46% of the pane- 
lists and approved if amended by another 19% (Figure 13, policy 
no . 1 ) . 

The level of support on the panel for some type of regula- 
tion of research was impressive. The particular policies having 
to do with the Commission's setting of policies for research, 
evaluating risks and benefits of research, and enforcement of 
guidelines and regulations received the support of as much as 
75% of the panel (Figure 13, policy nos. 2, 12, and 15). Lower 


130 


levels of support were indicated for procedures accomplished 
by the various review boards, and the lowest level was indi- 
cated for the boards themselves. Only 39% of the panelists sup- 
ported the particular policy describing Institutional Review 
Boards and 42% approved the particular policy establishing Region- 
al Review Boards (Figure 13, policy nos. 6 and 7). This distri- 
bution of responses seems to confirm the impression that the 
panelists objected to the establishment of additional layers 
of bureaucracy. 

The provision for a compensation fund for research subjects 
was supported as written by 56% of the panelists with an addi- 
tional 22% offering support if the policy were amended (Figure 
13, policy no. 16). Many of the amendments offered were in 
the direction of strengthening this aspect of the scenario. 

There were a considerable number of amendments addressed 
to limiting the scope of control accorded the Cornnriss'Lon in the 
policy scenario (Figure 13, policy nos. 1 and 9). This may 
have reflected a concern over the constitutionality of certain 
aspects of the scenario. 

Two major dimensions were identified in the panelists' 
responses to this policy scenario. They were: 

* Freedom of inquiry; and 

* Research productivity and quality. 

Freedom of inquiry . The most fundamental question implicit 
in panelists' responses was characterized by a panelist reviewer 
as follows: 

Does the scientific and research community have an abso- 
lute, inviolable autonomy which holds primacy over its 


131 


social responsibilities, or do the rights, freedom and 
protection of the subjects of human research hold an 
inviolable primacy over the advance of biomedical research? 

Expression of this question was manifest in the panel's focus 
on the legality and constitutionality of a national level of 
control of research in view of the "traditional freedom of 
science and research to set its own goals and priorities". On 
one side was a feeling that the level of control described in 
the scenario represented a serious infringement on the freedom 
of inquiry, while on another was the sense that the establish- 
ment of national priorities and goals, together with means of 
protecting individuals and society, had advantages which out- 
weighed the restrictions placed on the research community. Oppo- 
sition of scientists to extensive governmental and political 
control was also foreseen and the fight for freedom of inquiry 
was considered likely to be waged on constitutional grounds. 

Research productivity and quality . Negative effects of the 
policy were generally related to research productivity and qual- 
ity. Concern over the bureaucratic implementation of the policy 
— red tape, layers of bureaucracy, and administration by in- 
competents — w T as central to the notion that research would be 
harmed if the policy scenario were implemented. The scientific 
community, universities, private industry, and even Congress 
were seen as opposing the policy for reasons of cost or because 
the system would be constraining. 

The review boards provisions also drew attention. Some 
contended that support for such a bureaucracy would cut heavily 
into funds available for research; others noted that the poli- 


132 


Analysis 

and 

Evaluations 


cies described would be discriminatory to non-profit organiza- 
tions, particularly universities. 

However, panelists did see some positive effects stemming 
from the policy. Some of these included improvements in the 
quality of research through the review process, protection of 
human subjects of research and compensation for those harmed, 
and protection of the general public. Standardization of re- 
view procedures and formal standards for the treatment of human 
subjects were also considered beneficial since they would faci- 
litate research and ease some burdens on researchers. 

Both the amendments and the discussions of the policy scenario 
indicate substantial support for policies which would help to 
rationalize and make explicit the review of research proposals 
and the monitoring and review of the actual conduct of research 
to insure safety and to evaluate risks and benefits. However, 
there was opposition to development of these policies in the 
context of a complex bureaucratic system both because of the 
costs involved and because of the possible effects on research 
productivity. Panelists also feared that the particular poli- 
cies described in the scenario were potentially discriminatory 
to non-profit institutions, particularly private universities. 


133 


IMP L EMEN TAT I ON OF BIOMEDICAL AND BEHAVIORAL TECHNOLOGIES 

The fourth policy scenario described the Commission' s jurisdic- 
tion over the implementation of biomedical and behavioral tech- 
nologies. Particular policies established a classification of 
technologies and addressed the authority and responsibility of 
the Commission with respect to technologies in each classifica- 
tion. Commission responsibility related to assessment and 
evaluation of technologies. Commission authority extended over 
all biomedical and behavioral technologies and included the 
ability to prescribe sanctions for failure to observe guidelines 
and regulations. 

Findings A narrow majority of panelists supported this policy scenario. 

Overall, 52% of the panel supported the policy, while 33% were 
opposed (Figure 10). Social scientists were most frequently 
in support of the policy (65%), while medical scientists 
supported it least frequently (33%). The first policy statement 
in the scenario — describing the scope of the Commission’s 
jurisdiction over technologies — was supported by 46% of the 
panel, but opposed or found unnecessary by 26%. Opposition 
centered on the broad jurisdiction allowed the Commission in 
the scenario. 

The distribution of the panelists' votes on the particular 
policies and the amendments offered support the contention 
that concern over the scope of jurisdiction was central to 
the panelists' view of the scenario. Particular policies having 
to do only with the Commission' s jurisdiction were not well 
supported (Figure 14, policy nos. 1, 2, and 5). Support was 


134 


also not forthcoming when jurisdiction entailed constraints 
on providers (Figure 14, policy nos. 4, 10, and 14), except 
when this was clearly directed at the protection of individual 
patients (Figure 14, policy no. 9). 

Greater levels of support were offered for particular 
policies which had to do with monitoring, evaluating, and 
assessing technologies (Figure 14, policy nos. 7, 8, 11, and 
12). Apparently the concept of a comprehensive review and 
assessment of technologies was palatable to a majority of pane- 
lists. A majority was even willing to strongly support provi- 
sions for enforcement of penalties for failure to observe 
policies and guidelines (Figure 14, policy no. 13). 

Three major dimensions were identified in panelists' re- 
sponses to this policy scenario. They were: 

* Impacts on health; 

* Impacts on the marketplace; and 

* Jurisdictional conflicts. 

Impacts on health . A primary focus of this scenario was 
health, expressed either in terms of improvement in the health 
of individuals and society, or the prevention of harmful effects 
through the correct use of medical services and technology. 

Among the anticipated benefits of the Commission were: 
better public use of health information; decreased mortality; 
decreased morbidity from social-medical problems (e.g. drug 
addiction); heightened emphasis on the need for improved drugs, 
procedures and devices; quality control of medical and health 
technology with assurance of safety and efficacy; prevention of 


135 


misleading advertising; movement from subjective diagnostic and 
treatment procedures towards those more scientifically based; 
greater provider effort to improve products and services; and 
reduced consumer dependence on providers (physicians in particu- 
lar and the medical industry in general). 

The problems foreseen were generally ascribed to the level 
of control described. These included: the tendency to develop 

products aimed at large consumer markets with a commensurate 
decrease in effort on behalf of those with rare disorders; a 
decreased range of technologies that would be developed; denial 
of a patient's free choice of new innovative technologies; a 
lower level of health and medical care resulting from interfer- 
ence in the patient-physician relationship; and the demotion 
of psychiatry and placebos in medicine (paralleling increased 
use of psychotherapeutic drugs). 

Impacts on the marketplace . Another issue raised in this 
scenario was the impact of the proposed regulatory system on the 
marketplace. The majority of panelists foresaw a two-pronged 
attack whereby dangerous or questionable products and services 
would be abolished, leaving a much more limited range of choice 
for a public made more discriminating by the same system. 

However, certain costs in the form of latent consequences 
were also foreseen. Some panelists felt testing and evaluating 
drugs and other technologies would be so expensive and time- 
consuming that only large companies could provide the capital 
for development, thus driving individual or small-group efforts 
from the field. In turn the government would be open to a 


136 


Analysis 

and 

Evaluation 


variety of charges, including restraint of trade, abetting the 
growth of monopolies, inflating prices, retarding the develop- 
ment of needed drugs and procedures, and interfering with the 
free choice of individuals. An additional point made in this 
context was that many scientists and technicians would be di- 
verted from conducting their own scientific work to assessing, 
testing, and evaluating the work of others. 

Jurisdictional conflict s. Some panelists felt that the 
policy described in the scenario would create considerable con- 
flict with existing Federal agencies. The role of the Commission 
was seen as overlapping agencies, such as the Food and Drug Ad- 
ministration, and some panelists suggested revision of the scen- 
ario to provide policy-making powers to the Commission but leav- 
ing implementation with existing regulatory agencies whose func- 
tions would be clearly spelled out. 

Panelists expressed concern over the workability of this scenario 
While attracted by anticipated benefits relating to consumer 
protection and health, they foresaw problems in implementing 
a policy with so wide a scope — both from a constitutional view- 
point and from the practical perspective of whether the bureau- 
cratic structure described could operate effectively in the con- 
text of American society (particularly whether or not vested in- 
terest groups would co-opt or oppose the Commission) . 


137 


RESOURCE 


Findings 


ALLOCATION POLICY 

In 1975, the U.S. spent $118.5 billion on health, up from $71.6 
billion (1975 prices) in 1955. This amount represented 8.3% of 
the nation's Gross National Product (GNP) — the total market 
value of all goods and services — in 1975, compared to 4.6% in 
1955. 

Total health research and development (R&D) expenditures 
have also increased over the years — from $541 million (1975 
prices) in 1955 to $4,610 million in 1975. But as a percentage 
of all health expenditures they have decreased from a peak of 
4.9% in 1965 to 4.0% in 1975. 

Over the past ten years. Federal health R&D obligations 
have remained relatively constant as a proportion of total 
health R&D (62% in 1965, 61% in 1975) and as a proportion of 
all nonindustry (principally drug companies) health R&D (82% 
in 1965; 85% in 1975). The proportion of all Federal R&D obli- 
gations going to health R&D, however, increased from 8.0% in 
1969 to 13.3% in 1974, but dropped to 13.1% in 1975. During 
this same period total Federal R&D obligations declined steadily 
from 8.5% to 5.8% of Federal government outlays. The National 
Institutes of Health, which spent $1.9 billion in 1975, account 
for the majority of Federal health R&D expenditures (66% of the 
total of $2.8 billion). See Figure 15. 

The majority of panelists thought that in the future we should 
allocate: (1) a greater percentage of the nation's Gross 

National Product to health (85% said this); (2) a larger per- 
centage of the health dollar to health R&D (86%) ; (3) a greater 


138 


percentage of total Federal outlays to R&D (66%); and (4) a 
greater percentage of total Federal R&D funds to health R&D 
(88%). See Figure 16. There were no differences among panelist 
categories regarding preferred future allocations for health and 
health R&D. 

Based on 1975’s level of Federal health R&D expenditures 
($2.8 billion), panelists’ allocations among the different types 
of health R&D were essentially the same for 1975 and 1985. All 
panelists favored biomedical research over behavioral research, 
with the median panelist allocating $750 of every $1,000 to 
biomedical research (compared to $250 for behavioral research). 
Panelists’ division of the health R&D dollar within these two 
areas of research was basically identical. Preferred alloca- 
tions for each type of health R&D are shown in Figure 17. 

There were few differences among panelist categories with 
respect to allocating the health R&D dollar among types of re- 
search. Basic research was funded most heavily ($235 of every 
$1,000), particularly by medical scientists ($258 of every $1,000) 
Representatives of the public interest wanted health services re- 
search funded more heavily than basic research, allocating $175 
of every $1,000 to the latter and $256 of every $1,000 to the 
former. 

Analysis 
and 

Evaluation 


Panelists agreed almost unanimously that a greater proportion 
of the nation’s resources should be devoted to health activities, 
and that a greater proportion of the health dollar should be 
spent on R&D. In general, panelists also agreed that greater 
emphasis should be placed on health services and quality assur- 


139 


ance research and less emphasis on basic research than is the 
case at present. Since no data on the level of Federal funding 
for each type of research are available, comparisons are diffi- 
cult to make. Nevertheless, in 1975 the National Institutes of 
Health accounted for 66% of all Federal health R&D, yet, accord- 
ing to the median panelist, only $550 of every $1,000 (including 
management monies) should go for technology development research 
(basic and applied research). Moreover, in 1974 2.9% of Federal 
health R&D funds were spent on delivery of health care R&D, yet 
the median panelist thought that $160 of every $1,000 (including 
management monies) should go for health service delivery research, 
not counting quality assurance and education research. 


140 


Figure 9 

A SYNOPSIS OF THE FOUR POLICY SCENARIOS (1) 

Ho. 1: Permanent National Commission 

The first policy scenario described a Permanent National 
Commission on Biomedical and Behavioral Research and Technology 
established by an Act of Congress. Particular policies addressed 
organization of the Commission, membership, staffing, level of 
authority, scope, accountability, and evaluation of the Commis- 
sion's performance. The Commission was described as having a 
national level of authority which included promulgation of 
policies and guidelines, the establishment of a national strategy 
for public funding of research, and the auditing of research 
projects . 

No. 2: Public Involvement in Policy Decision-Making 

The second policy scenario described provisions of the Act 
designed to encourage public involvement in decision-making 
and the dissemination of information to the public. Parti- 
cular policies addressed the Commission's responsibilities with 
respect to public participation, the gathering of public opinion, 
and the means and standards for dissemination of information. 

The policies also specified the creation of five federally 
funded regional information centers to support the involvement 
and dissemination efforts. 

No. 3: Biomedical and Behavioral Research 

The third policy scenario described the Commission's jurisdic- 
tion over biomedical and behavioral research. Particular 
policies indicated the scope of Commission authority, specified 
policies with respect to the review of research proposals, 
described the establishment and organization of Regional Review 
Boards and Institutional Review Boards, and described the crea- 
tion of a compensation fund for subjects of research. Policies 
dealing with the review boards described responsibilities, 
membership, staffing appeals processes, and evaluation. 

No. 4: Implementation of Biomedical and Behavioral Technology 

The fourth policy scenario described the Commission's jurisdic- 
tion over the implementation of biomedical and behavioral tech- 
nologies. Particular policies established a classification of 
technologies and addressed the authority and responsibility of 
the Commission with respect to technologies in each classifica- 
tion. Commission responsibility related to assessment and 
evaluation of technologies. Commission authority extended over 
all biomedical and behavioral technologies and included the 
ability to prescribe sanctions for failure to observe guidelines 
and regulations. ^ 

(1) See Appendix 6 for a full description of each policy scenario. 


141 


Figure 10 

DEGREE OF SUPPORT (OR OPPOSITION) FOR IMPLEMENTING THE POSSIBLE NATIONAL 
POLICY DESCRIBED IN THE FOUR POLICY SCENARIOS DESCRIBED IN THE THIRD PEI, 
BY CATEGORY OF PANELIST (1) 



Scenario No. 1: Permanent National 

Commission 


Generally support, as written 

16 

12 

8 

12 

11 

59 

54% 

Support, with amendments 

7 

5 

9 

6 

5 

32 

29% 

Generally oppose 

2 

3 

7 

2 

4 

18 

17% 

Total 

25 

20 

24 

20 

20 

109 

100% 

Scenario No. 2: Public Involvement 

in Policy Decision-Making 

Generally support, as written ... . 

10 

9 

7 

13 

9 

48 

44% 

Support, with amendments 

6 

4 

3 

2 

2 

17 

16% 

Generally oppose 

8 

7 

14 

5 

9 

43 

40% 

Total 

24 

20 

24 

20 

20 

108 

100% 

Scenario No. 3: Biomedical and 

Behavioral Research 

Generally support, as written 

19 

12 

11 

15 

10 

67 

63% 

Support, with amendments 

1 

4 

5 

1 

5 

16 

15% 

Generally oppose 

4 

4 

8 

2 

5 

23 

22% 

Total 

24 

20 

24 

18 

20 

106 

100% 

Scenario No. 4: Implementation of 

Biomedical and Behavioral Technology 

Generally support, as written 

14 

10 

8 

11 

13 

56 

52% 

Support, with amendments 

4 

4 

4 

3 

1 

16 

15% 

Generally oppose 

6 

6 

12 

5 

6 

35 

33% 

Total 

24 

20 

24 

19 

20 

107 

100% 

(1) 110 of 125 panelists (88%) completed 

the 

third 

PEI. 






(2) Self-assigned categorization. 

(3) See Appendix 6 for a full description of each policy scenario. 

(4) Panelists were classified according the mean score of their responses to each 
of the particular policies contained in the policy scenario. Scale point 5 
(unnecessary) was equated with scale point 4 (oppose in any form). Panelists 
with a mean score of 1.000 to 1.750 were classified as "generally support as 
written"; those with a mean score of 1.751 to 2.499 as "support, with amendments"; 
and those with a mean score of 2.500 or greater as "oppose the policy". 


142 


Figure 11 

PANELISTS’ VOTES OF THE PARTICULAR POLICIES THAT COMPRISED POLICY SCENARIO NO. 1, 

PERMANENT NATIONAL CCl'A'ISSIO'J , THIRD PEI 



1. 

A National Commission (N=109) 

51 

26 

13 

6 

5 

2. 

Purpose of the Commission (N=108) 

32 

29 

25 

12 

2 

3. 

Composition of the Commission (N=107) .... 

30 

33 

24 

10 

3 

4. 

Terms of Appointment of the Commissioners 
(N=108) 

44 

35 

12 

7 

2 

5. 

Commission Staff (N=108) 

74 

12 

1 

6 

7 

6 . 

Commission Policies, Guidelines, and 
Regulations (N=107) 

44 

23 

19 

11 

3 

7. 

Commission Approval of Policies (N=107) .. 

59 

15 

13 

9 

4 

8. 

Appeals to Commission (N=107) 

48 

20 

15 

13 

5 

9. 

Commission Audits Research (N=107) 

53 

21 

7 

14 

6 

10. 

A National Strategy for Research (N=108) . 

50 

16 

15 

15 

5 

11. 

Allocation of Research Funds (N=106) 

22 

26 

25 

24 

5 

12. 

Commission Meetings (N=107) 

49 

28 

8 

7 

8 

13. 

Procedure for Establishment of 

Policy by Commission (N=106) 

57 

22 

10 

7 

5 

14. 

Public Dissemination of Commission 
Policies (N=107) 

82 

8 

3 

5 

3 

15. 

Application of Commission Policies 
(N=106) 

43 

9 

20 

25 

4 

16. 

Penalties (N=108) 

45 

17 

16 

19 

4 

17. 

Self-Evaluation by the Commission (N=106) 

60 

17 

8 

9 

6 

18. 

Congressional Evaluation of the 

Commission (N=106) 

65 

18 

4 

7 

7 

19. 

Annual Report to Congress (N=107) 

83 

4 

2 

5 

7 


(1) See Appendix 6 for a full description of each particular policy. 


143 


Figure 12 

PANELISTS' VOTES OF THE PARTICULAR POLICIES THAT COMPRISED POLICY SCENARIO NO. 2, 
PUBLIC INVOLVEMENT h'l POLICY DEClSIOE-EAKJEG, THIRD PEI 



1. 

Public Involvement in Policy Decision- 
Making (N=106) 

44 

26 

16 

9 

5 

2 . 

Public Access to Meetings and 

Materials (N=106) 

66 

22 

9 

1 

3 

3 . 

Responsibility to Inform the Public 
(N=107) 

63 

16 

7 

8 

7 

4 . 

Commission Conducts Studies of 
Implications (N=107) 

79 

8 

3 

4 

7 

5 . 

Commission Sets Standards of Consumer 
Education (N=106) 

49 

28 

8 

13 

9 

6 . 

Commission Undertakes National Opinion 
Surveys (N=107) 

51 

14 

14 

12 

9 

7. 

Five Information Centers (N=107) 

19 

28 

15 

24 

14 

8 . 

Selection of Centers (N=106) 

39 

18 

7 

25 

11 

9 . 

Governance of Centers (N=104) 

39 

14 

6 

27 

14 

10. 

Center Appropriations (N=106) 

26 

18 

15 

31 

9 

11. 

Purposes of the Centers (N=107) 

50 

9 

9 

22 

10 

12. 

Review and Evaluation of the Centers 
(N=105) 

41 

15 

8 

22 

14 


(1) See Appendix 6 for a full description of each particular policy. 


144 


Figure 13 

PANELISTS' VOTES OF THE PARTICULAR POLICIES THAT COMPRISED POLICY SCENARIO NO. 3, 

BIOMEDICAL AND BEHAVIORAL RESEARCH, THIRD PEI 



1. 

Commission Jurisdiction over Biomedical 
and Behavioral Research (N=106) 

46 

19 

18 

16 

1 

2. 

Commission Policies, Guidelines, and 
Regulations (N=104) 

65 

14 

14 

4 

3 

3. 

Commission Review of Research Projects 
(N-105) 

51 

16 

14 

16 

3 

4. 

Researchers Interpret Commission 

Policy (N=106) 

59 

15 

6 

17 

4 

3. 

Institutional and Regional Review Boards 
(N=106) 

52 

24 

10 

11 

3 

6. 

Institutional Review Boards (N=106) 

39 

29 

14 

13 

5 

7. 

Regional Review Boards (N=106) 

42 

29 

9 

15 

5 

8. 

Submission of Research Proposals (11=105) 

50 

27 

9 

11 

4 

9. 

Categories of Researchers Covered (N=104) 

61 

14 

6 

16 

3 

10. 

Decisions on Funding Research Proposals 
(N-106) 

58 

16 

9 

13 

4 

11. 

Board Review for Adherence to Guidelines 
(N-106) 

55 

22 

5 

15 

4 

12. 

Enforcement Authority of the Commission 
(N=106) 

60 

15 

8 

14 

3 

13. 

Appeals to the Commission (N=106) 

60 

14 

9 

12 

5 

14. 

Monitoring of IRB, by RRBs (11=104) 

49 

17 

11 

16 

7 

15. 

Annual Review of Research (N=104) 

75 

12 

2 

9 

3 

16. 

Compensation Fund for Research Subjects 
(N=105) 

56 

22 

11 

7 

4 


(1) See Appendix 6 for a full description of each particular policy. 


145 


Figure 14 

PANELISTS' VOTES OF THE PARTICULAR POLICIES THAT COMPRISED POLICY SCENARIO NO. 4, 
IMPLEMENTATION OF BIG4EDICAL AND BEHAVIORAL TECHNOLOGIES, THIRD PEI 



1. 

Commission Jurisdiction over Technologies 
(N=105) 

46 

13 

14 

23 

4 

2. 

Classification of Tangible and Intangible 
Technologies (N=107) 

37 

22 

17 

22 

2 

3. 

Classification by Use and Safety (N*105) . 

61 

13 

6 

16 

4 

4. 

Commission Sets Policies for Application 
of Technology (N=106) ...... 

41 

18 

16 

25 

1 

5. 

Assessment of Technologies by DHEW 
Agencies (N=104) » 

44 

17 

16 

19 

3 

6. 

Assessment Prior to Application or Use 
in Practice (N=105) 

64 

14 

4 

13 

5 

7. 

Independent Assessment of Technologies 
(N=104) 

50 

23 

12 

14 

1 

8. 

Action on Assessments (N=104) ...... 

53 

18 

7 

Iff 

4 

9. 

Descriptions of Intangible Technologies 
(N-103) 

51 

15 

9 

24 

2 

10. 

Application for Approval as Standard 
Medical Practice (N=105) . 

41 

20 

11 

25 

3 

11. 

Evaluation of Existing Technologies 
(N-105) 

59 

14 

8 

16 

3 

12. 

Procedures for Monitoring Approved 
Technologies (N=105) 

54 

22 

6 

15 

3 

13. 

Penalties for Failure to Observe 
Policies and Guidelines (N=104) 

53 

18 

8 

18 

3 

14. 

Licensing of Providers (N=103) 

46 

14 

13 

23 

5 


(1) See Appendix 6 for a full description of each particular policy. 




146 


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147 


Figure 16 

MEDIAN PANELIST'S RESOURCE ALLOCATIONS, 1980 AND 1985, THIRD PEI 


Resource Allocation (1) 



Percentage of Gross National Product that the U.S. should 
spend on health (all personal and other health services, 

health R&D, etc.) N=97 8.3 10.0 10.5 

Percentage of total U.S. health expenditures that should be 
spent on health R&D (basic and applied research, quality assur- 
ance and health services research, and consumer and provider 


education research, etc.) N=97 4.0 6.0 7.0 

Percentage of federal government outlays that should go for R&D 

(defense R&D, space R&D, health R&D, etc.) N=9S 5.8 6.1 7.0 

Percentage of total federal R&D funds that should be spent on 
health R&D (basic and applied research, quality assurance and 
health services research, and consumer and provider education 

research, etc.) N=95 13.1 15.0 16.0 


(1) "N" indicates the number of panelists who completed this item. 

(2) Actual figure. 


148 


Figure 17 

MEDIAN PROPORTION OF FUNDS THAT SHOULD BE ALLOCATED TO EACH TYPE OF MEDICAL 
RESEARCH IN 1975, ACCORDING TO PANELISTS (1) 



(1) Proportions based on $1,000. Where necessary, median values normalized 
to equal totals indicated (N=83). 


149 


Chapter 5: 

Implications of Policies. 




151 


INTRODUCTION 


The implications of the policy scenarios were derived from 
three sources. They were: 

* Reports on the salient dimensions of each policy 
scenario, provided by panelist reviewers; 

* Reports on the salient dimensions underlying the 
responses to all policy scenarios, provided by two 
panelist reviewers, one who supported the Commission 
and one who opposed it; and 

* Two position papers, one written by a panelist who 
supported the Commission 3 the other by a panelist 
who opposed it. 

The implications of the policy scenarios highlight those 
major issues which appeared to shape panelists' views on the 
Commission and its policy and regulatory functions. The dimen- 
sions identified are those which cut across the four policy 
scenarios, and on which consistent ideas and opinions were found. 
Each dimension raised divergent views and there was a variety 
of opinions on just what factors underlay those diverging views. 

The position paper writers articulated their viewpoints 
from perspectives in political philosophy. The position paper 
author in favor of the Commission observed: 

Government should be involved in restoring equilibrium 
between the rights of the individual and the needs of 
society in biomedical and behavioral research. 

The opposite viewpoint contended that the Commission and its 

attendant functions was 

...inconsistent with basic values concerning autonomy/ 
freedom, understood either as embodying intrinsic justice/ 
fairness values, or as an efficient decentralized spontan- 
eous ordering system for a complex production/distribution 
system — including biomedical research. 

However, not all panelist reviewers saw the diverging viewpoints 


152 


as grounded in political philosophy. One panelist reviewer 
thought the issues were more pragmatically based in relation 
to political power. 

Biomedical/behavioral research has acquired, or it may 
acquire the abilities to cause, prevent, and cure di- 
sease; the abilities to alter and direct the nature and 
structure of man and other living things; and through 
these accomplishments it is conceivable that science 
might acquire the power to control individuals, peoples, 
nations, indeed mankind. "Brave New World" in its most 
diabolical aspects is a new reality, at least in the 
minds of the current politically powerful. History has 
shown us that existing power yields most unwillingly to 
emerging power. At issue is power, and at play is fear, 
fear of the loss of power. 

Whatever the ideological or philosophical basis underlying 
panelists' views, they wanted to achieve the same ideals. All 
panelists wanted to save money, or use money more productively. 
They wanted to cut red tape and to provide some kind of struc- 
ture which would allow good projects to come to the fore while 
the bad would be weeded out. The panelists wanted any Canmis- 
siorij or Commission-like structure, to be both responsive to the 
public and immune from political influence. Finally, the panel- 
ists seemed to agree that more and better public education is 
either desirable or necessary (differing on whether the public 
really wants such education or if it can absorb it). 

Agreeing on these ends as desirable, the panel disagreed 
over the means of achieving them, and they reflected that disa- 
greement throughout their responses. Five dimensions were iden- 
tified in panelists' responses. They were: 

* The need for controls; 

* The role of government; 


* 


Justice; 


153 


* Economic factors; and 

* Public participation. 

In the remainder of this chapter, the implications of the 
policies are discussed in relation to these five themes. 


154 


THE NEED FOR CONTROLS 

One of the fundamental issues brought to light in the study was 
a clash of values over the need, the extent, and the means of 
control over biomedical and behavioral research and technology. 
At one extreme were those favoring the continuance of the pre- 
sent loosely-knit system of controls and regulations for norma- 
tive conditions, with ad hoc measures for emergencies, perhaps 
to include an ombudsman service rather like the present Commis- 
sion. At the other end were those enthusiastically in support 
of the Commission described in the policy scenarios, one which 
would have the power to regulate all research and implementa- 
tion, at all stages, whether publicly or privately financed in 
order to eliminate present abuses and prevent future ones. 

The sentiments expressed ranged from the desirability of 
controls only when necessary to protect individuals and the 
collective good, to the desirability of organizing and direct- 
ing individual behavior (e.g., the researcher's behavior and 
the selection of his research project) in line with social 
consensus . 

The regulatory view held that society should establish 
the priorities for research, select the research project and 
monitor the results closely. The researcher was seen, ideally, 
as the agent of society. Panelists holding this view considered 
the present research system as laissez-faire, uncontrolled and 
indifferent to social needs. Today's researchers were sometimes 

viewed with suspicion, distrust and hostility. One panelist 
reviewer characterized this view as follows: 


155 


Accountable to no one but their consciences, medical 
researchers have squandered millions of dollars of tax- 
payer funds for no demonstrable purpose or gain, and, in 
the process, have abuse countless research subjects. When 
asked for a public accounting, researchers balk, and justi- 
fy all their efforts on the benefits accrued to mankind 
by research efforts, generally efforts produced by someone 
else . 

Implicit contradictions about the role of researchers and 
their relationship with industry, usually represented by the 
pharmaceutical companies — "everyone's favorite whipping boys" 

— were also to be found. As some panelists pointed out, poli- 
cies such as those described in the scenarios would give contin- 
uous, visible publicity to the fact that the biomedical/biotech- 
nical market is glutted with highly advertised, largely unassessed 
diagnostic and therapeutic procedures and products which may at 
best be ineffectual and at worst dangerous. Research and indus- 
try were frequently seen as one and the same by those favoring 
greater regulation, and the researcher was depicted in two 
negative roles, entrepreneur of applied technologies, and in- 
dependent pursuer of basic knowledge. 

Many panelists, particularly those among the group opposed 
to [the scenario Ccrmtss'icrr . ] , seemed to view the researcher 
as a lonely, individual hero, pregnant with contributions 
to mankind but harassed by a bureaucracy staffed with 
mediocrities or czars. 

These panelists tended to rely on professional controls exerted 
by the individual and his peer group, and with the usual inter- 
change of direct and indirect pressures from society at large. 


156 


THE ROLE OF 


The View of 
Those 
Supporting 
the 

Commission 


GOVERNMENT 

A great range in attitudes was displayed towards bureaucracy, 
from the position that it is 

...an opprobrious term applied by dissenters as a general 
critism of the slow but careful working of government ma- 
chinery in a democratic society, to a distaste and dis- 
trust for what was seen as the ineffective and inefficient 
bureaucracy and the bureaucratic mode. 

The panelists who favored regulation emphasized the expected 
beneficial results. The Commission was regarded by these 
panelists as an effective coordinating and planning mechanism, 
apolitical, responsive to the commonweal and capable of rational 
planning with elimination of waste and duplication. Supporters 
depicted the Commission as an essential vehicle for providing 
representation and balance in government commensurate with the 
growth of science and the social importance of technology in 
the contemporary world — a "biomedical Supreme Court". 

Further, the Commission would provide a background con- 
sensus which would serve as the basis for legal determinations, 
thus strenghtening and clarifying law in the areas of research, 
science, and medicine. Particularly crucial was the determina- 
tion of nationally uniform definitions of life and death to 
clarify legal ambiguities now surrounding euthanasia, abortion, 
organ donorship, malpractice, and so forth. Coalescence of now 
widely disparate agencies, such as the Food and Drug Administra- 
tion and the National Institutes of Health, was favored by sup- 
porters of the policies described as an effective method to re- 
duce costs, duplications, and gaps in services, and thereby better 
coordinate the conduct of research and the delivery of care. 


157 


The View of 
Those 

Opposing the 
Commission 


The fear on the part of some in support of the Commission 
was that powerful and antagonistic interests would reduce it to 
a shadow agency, perhaps worse than no agency at all. Present 
regulatory agencies, jealous of domain, could contest every func- 
tion, or submit to the letter but not the spirit, while other 
internal political pressures could tend to compromise or dis- 
credit the Commission's integrity. External interests such as 
medical and behavioral scientists (organized medicine and re- 
searchers), and industry (the pharmaceutical companies) could 
cause similar problems. 

Those generally opposed to the Commission , or who wished to 
amend it, regarded the increased bureaucracy as formidable and 
an insurmountable problem in itself. Among the negative conse- 
quences predicted was that an over-large, over-centralized Com- 
mission would stifle research with red-tape and conflicting regu- 
lations. Centralization, itself, was seen as a step toward 
effecting a more restrictive control over researchers, industry, 
and providers. Those panelists opposed to the Commission also 
believed that it would be remote from Congressional direction, 
and unresponsive to those within its hegemony. Some felt the 
lay majority on the Commission would be a serious obstacle to 
progress. The conflict between expert and lay expositions of 
biomedical and behavioral issues might well make Commission 
deliberations vulnerable to hearsay evidence and ignorant pole- 
mics. There was also the concern that the growth of a research 
bureaucracy would either favor entrepreneurial researchers who 


could manipulate red-tape requirements over truly creative indi- 


158 


viduals, or freeze out all but the most pedestrian and safe 
types of research. The review system could be abused to delay 
or kill research which did not have an established proponent 
somewhere on the Commission staff. 

Some panelists viewed the aims of the Commission as good, 
but did not think that such a national policy could accomplish 
all the things set forth in the scenarios. These panelists 
doubted that a new governmental agency could function differ- 
ently from present agencies or avoid being subject to the same 
ills. As part of the system it would be potentially dangerous 
— the "scientific gestapo" and "science czars" — because of 
the extensive powers granted to it. 

Those panelists who opposed the Commission completely argued 
with conviction that the very worst was sure to occur. For those 
panelists, chiefly scientists and researchers, the fear that an 
essentially "lay" superstructure would be all administration and 
no substance was quite clearly expressed. 


159 


ECONOMIC FACTORS 


Potential 

Economy 


Potential 

Burden 


The distribution of economic resources was a concern for most 
panelists in at least one of three contexts: the cost of medi- 

cal research; the cost of health care delivery; and the cost of 
operating the Commission and its attendant bureaucracies. 

For many, the high cost of current research, exacerbated by 
duplicatory efforts, lack of goal-directiveness, the high fees 
and salaries of providers and researchers, etc., justified the 
creation of a Permanent National Commission. There was a hope 
that the review and coordination of biomedical and behavioral 
research and the delivery of care would result in a just dis- 
tribution of available funds, commensurate with a national 
policy defining goals and priorities. 

It was noted repeatedly that the national system of health 
care research and delivery is the most expensive in the world, 
though probably not the best. The Commission could provide the 
means to slow the trend of the past several years toward an 
ever-higher proportion of the nation's resources being expended 
on the national health budget. For example, by adopting uniform 
national definitions, e.g., "standard medical practice", money 
will be saved in insurance premiums and malpractice awards. In 
fact, some expected that lawyers as middle-men would be elimi- 
nated on this front because of the compensatory fund the Commis- 
sion would oversee for those harmed iatrogenically or in the 
course of participating in research projects. 

But even for the many supporters of the concept, there was a 


160 


concern that the Commission would present a massive bureaucracy 
that could dramatically escalate the cost of research and delivery 
while not saving anything near what its operational expenditures 
might be. The cost of staffing and operating the Commission 3 
generating public involvement, etc., could prove astronomical. 
Additionally, the practice of financing each of these components 
might well nurture public naivet£ and the belief that money can 
buy almost any result. The information centers were singled 
out, particularly, as likely to produce a plethora of rhetoric 
at an enormous expense. 

Besides the direct costs in tax dollars for operating the 
Commission _, the public, in the role of consumer, would pay ad- 
ditionally in the marketplace. Costs borne by producers of bio- 
medical goods and services for testing and reviewing their pro- 
ducts, and disseminating educational information about them, 
would be passed on to the consumer in the form of higher prices. 
However, non-profit organizations, such as universities, would 
have to absorb such costs in lieu of parallel constituencies 
to pass them on to. Such economic factors were viewed as so 
important as to be one of the most-cited barriers to implementing 
the Commission: 

Perhaps these financial considerations should be part 
of the public decision as to whether the best thing we 
can do now is a narrow effort directed at curbing the 
real abuses we know (or suspect) exist, or a more wide- 
ranging effort to do good unilaterally. 


161 


JUSTICE 


Protection 
of Human 
Subjects 


Justice was a pervasive moral principle expressed throughout 
the policy scenarios. This was addressed in terms of rights 
of the individual; equality of opportunity (even for researchers 
to get trants); the need for appeals processes; the provision 
of standards (so that persons are treated fairly and equally); 
harmful effects when politicization of a procedure and a regula- 
tory system occurs; the need for safeguards for special groups 
— e.g., children, prisoners, the poor, and minority groups; 
dangers of over-centralizacion; dangers through excessive homo- 
geneity of a society; and the need for compensation for all 
effects from research. 

Panelists differed in their perceptions of justice. One 
of the continuing conflict areas among them was rights of the 
individual versus rights of society or social groups, or rights 
of social groups or institutions (e.g., universities, academic 
groups, businesses, privately funded research) versus those of 
society. Hope was expressed that a Cormission such as that 
described might provide the means by which society could resolve 
some of these conflicts among rights and thus establish the 
foundation for law in this area. 

Panelists supporting the Corrsvission cited the protection of 
human subjects as an important gain. Opponents made little men- 
tion of this matter and so it was difficult to know if they re- 
garded it as a major problem requiring new methods of solution, 
or if the Corrmiss'lon was considered to be a solution in itself. 


Numerous positive consequences were expected. Better super- 


162 


Commission 
as Watchdog 


vision of the conduct of research involving human subjects would 
be an improvement over the auditing and reviewing done by insti- 
tutional boards, and over existing procedures for informed con- 
sent. National minimal standards would be assured and would re- 
sult in well-established guidelines that might become the basis 
for articulated international ethical codes. The new standards 
would ensure more protection for persons who are participating 
in research projects and increase the researchers’ awareness of 
their responsibilities. A need was seen for this system where 
there are no institutional review boards. 

Sometimes the Commission was seen as a watchdog that polices the 
scientific world for evidence of abuse. Certain practices would 
become specifically proscribed and penalties levied. These 
watchdog and police functions were regarded as punitive in tone 
by some, however, and rejected on this ground. 

Medical scientists inveighed against the restriction of 
the rights of biomedical and behavioral researchers to pursue 
their interests in a climate of freedom. Some of the policies 
described in the scenarios were viewed by them, and by some 
other panelists, as a violation of their individual liberties, 
albeit in the name of the public good. 

Most panelists did not connote the regulation and direction 
of research with infringement of researchers' civil liberties, 
however. Rather, the nature of research was seen as legitimately 
being subordinated to the dictates of society, this being the 
best way to achieve equity all around. 


163 


PUBLIC PARTICIPATION 

Many panelists seemed to find a value in public participation 
even beyond the reciprocity of ideas and influences between 
(and among) sectors of the public and those directly involved 
in either research and development or the regulation of biome- 
dical and behavioral technologies. They perceived this aspect 
of the national policy described as providing a general stabi- 
lizing influence on society. Some of the anticipated effects 
seen by this group were: less polarization on important issues; 

shifting of responsibilities for public policy onto a broader 
base; strengthening and clarifying the law by providing back- 
ground consensus; providing a buffer between politics and re- 
search; demonstrating the responsiveness of government; informing 
the public that they have a voice that is heard; restoring confi- 
dence in science; giving the public a feeling of participating 
in scientific matters; establishing order out of chaos; antici- 
pating new problems and situations so that the public can be 
informed before the new problems suddenly appear; and assisting 
the public to become less dependent on physicians. 

On the other hand, some panelists were concerned that not 
all of the results of public participation would be beneficial. 
There was a distinct fear that dogma could be substituted for 
dialogue in confrontations between the public and the Commission. 
The Commission itself could lead to a false sense of security — 
that "something was being done". Furthermore, the emphasis on 
rules and regulations might itself generate a public loss of 


faith in researchers. 




165 


Chapter 6: 

Public Understanding and Attitude. 






167 


INTRODUCTION 

The Study Design and Management Group recommended, and the Com- 
mission agreed, that a national survey of public opinion be con- 
ducted as an adjunct to the policy study in order to address 
that item of the study mandate which called for "an analysis 
and evaluation of public understanding" of the implications of 
advances in biomedical and behavioral research. 

The national opinion survey was closely integrated with the 
policy study, and the questionnaire was partially based on mater- 
ial generated by the first and second Policy Evaluation Instru- 
ments (PEIs). The questionnaire was administered to a probabili- 
ty sample of 1,679 Americans in individual face-to-face inter- 
views in the fall of 1976. In order to provide a basis for eval- 
uating public understanding and attitude, a parallel version of 
the questionnaire was included in the third PEI sent to consul- 
tant panelists. 

In this chapter, the findings of the national opinion sur- 
vey are reported and the responses of the general public are com- 
pared and contrasted to those of the consultant panelists. 

Survey findings are described under five headings. They are: 

* Advances and their effects; 

* Application of selected advances; 

* Rules about research, safety and efficacy of tests 

and treatments, financial responsibility for treatment; 

* Research priorities; and 

* Value received for dollars spent, future outlook. 

A brief analysis and evaluation is provided at the end of each 
set of findings. 


168 


ADVANCES AND THEIR EFFECTS 

Findings Knowledge of advances. Seventy-seven percent of Americans 

could name at least one new test, treatment, or item of new 
medical knowledge that has come about in the last twenty years. 
Knowledge of advances was found to be related to education, occu- 
pation, and income. For example, 92% of college graduates and 
86% of high school graduates could name at least one new test, 
treatment, or item of knowledge, while only 61% of those who 
did not graduate from high school could do so. 

Four classes of tests, treatments, and knowledge made 
possible in the last 20 years were mentioned by at least ten 
percent of respondents. Prevention , cure of oanoer was men- 
tioned most often — by 56% of those interviewed who could 
think of at least one new item (Figure 18). 

Access to advances . Neither the public nor the panel felt 
that all types of Americans can equally get the new tests and 
treatments made possible by medical research (Figure 19). 
Responses to this question, like those on general knowledge of 
advances, appeared to be related to education. The panel was 
overwhelmingly of the opinion that there was not equality of 
access (91%), while the public in general was less certain (60%). 
However, 73% of college graduates among the public held this 
opinion, compared to 41% of those who did not graduate from high 
school. Two- thirds of the public, and virtually all panelists, 
mentioned the poor and disadvantaged as Americans who did not 
have equal access to new tests and treatments even when they need 
them. Rural people were also mentioned frequently by the panel. 


169 


but not by the public — not even by those living in rural areas. 
There was little agreement (21% of the public and 7% of the 
panel) that if new tests and treatments cannot be made avail- 
able to all who need the, it is better not to develop them at 
all. 

Who gets a new test, treatment? The majority of the public 
(70%) and panelists (86%) thought that today people who can pay 
for a new test or treatment, or who know an important doctor 
were those most likely to get it when it first comes out, and 
there is limited availability (Figure 19). This view was partic- 
ularly prevalent among those who thought that not all types of 
Americans have equal access to new tests and treatments. Most of 
the public and the panel thought that people who apply first 
for tests or treatments or those who need them most should get 
a new test or treatment. Seventy percent of the public who 
thought new tests and treatments should be distributed on the 
basis of need thought rules should be set up to decide which 
people most need them, and the majority of these respondents 
(66%) thought that researchers, scientists, and doctors should 
have the final say about such rules. 

Best advances and their effects . A plurality of both the 
public and the panel agreed that the Prevention of infectious 
diseases has had the greatest good effect on society; 24% of 
the public (18% of panelists) specifically mentioned Prevention 
of poUo (Figure 20). However, the public and the panel showed 
little similarity in their choices of "best advance" after this 
initial agreement. Twenty-six percent of the public (but only 


170 


1% of panelists) mentioned Prevention , treatment of cancer; 

12% of the public mentioned Organ transplantation 3 by-pass 
surgery 3 radical surgery (but only 4% of panelists). Only 4% 
of the public mentioned Improved contraception (2% mentioned 
The pill), compared to 16% of panelists (11% of all panelists 
mentioned The pill). 

Health effects were predominantly mentioned as outcomes of 
the new test, treatment, or knowledge that has had the greatest 
good effect on society (Figure 20). The most frequently men- 
tioned among these were decreased morbidity ; increased longevtty , 
and decreased stigma and fear. Technical effects, predominantly 
the generation of new knowledge, and ethical effects were promi- 
nent among panel mentions, but were of minor significance among 
public responses. 

The effects mentioned by the public in relation to the new 
test, treatment, or knowledge of the last 20 years having the 
greatest good effect on society are shown in Figure 21. 

Worst advances and their effects . Only 52% of the public 
who could think of a new test or treatment, or item of know- 
ledge made possible in the last 20 years mentioned a specific 
item as having had a bad effect on society; 77% of panelists 
did so (Figure 22). Among those who mentioned a "worst advance" 
Improved contraception was mentioned most often by the public 
(23%), and Treatment for mental illness most often by panelists. 
Drug therapies and Proliferation of tranquilizers were mentioned 
specifically by 21% of panelists and 17% of the public. Social 
and ethical effects were among those most often mentioned in 


171 


connection with the new test, treatment, or knowledge that has 
had the worst effect on society (Figure 22). Health effects 
were not as prominent as they were in advances that have had 
the greatest good effect on society. The effects mentioned by 
the public for each advance are shown in Figure 23. 

Best future advances and their effects . The most desirable 
future advance identified by both the panel and the public was 
Prevention , treatment of cancer. Of those responding, 73% of 
the public mentioned this advance and 59% of the panel (Figure 
24). Prevention, treatment of cancer was also the first choice 
of both public and panel as the advance most likely to have a 
good effect on society in the next twenty years, though not fey 
as wide a margin. Slightly over half of the public responding 
to the question (52%) selected this advance, but only 15% of 
the panel (Figure 25). 

The most notable differences between the panelists' choices 
of best advances and those of the public were: Improved health 

services, access, availability (mentioned by 9% of panelists but 
only 2% of the public); and Health education, knowledge (men- 
tioned by 11% of panelists but only 3% of the public). 

Health effects, such as decreased morbidity, increased 
longevity and decreased stigma and fear predominated in the 
advance that will have the greatest good effect on society in 
the next 20 years, as they did in the case of the advance that 
has had the greatest good effect on society in the last 20 years 
(Figure 25). The effects foreseen for the various advances men- 
tioned by the public are shown in Figure 26. 

I 




172 


Worst future advances and their effects . Seventy four 
percent of panelists named a new item which would have the worst 
effect on society in the next 20 years, but only 36% of the 
public did so. There were striking differences between pane- 
lists and public as to what the worst new development will be 
(Figure 27). The public most frequently named Treatment for 
mental illness (14% of those among the public mentioning an 
item; 9% of panelists) and Selection of sex of offspring (13% 
vs. 4%). Panelists mentioned Control of behavior most often 
(23% of panelists; 3% of the public). The fact that the opinion 
survey questionnaire included specific items on the selection of 
sex of offspring may have triggered this response. However, 
there were more items in the questionnaire related to the con- 
trol of behavior than there were on the selection of sex of off- 
spring. 

Other noticeable differences between panel and public over 
the worst future advances were: Improved contraception (not 
mentioned by any panelist but by 8% of the public); and Life- 
extending equipment; artificial life support organs (mentioned 
by 15% of panelists but only 4% of the public). The most fre- 
quently mentioned effects of the worst future advances were not 
health effects, but political, environmental, ethical, individual 
and social effects (Figure 27). The effects for each advance 
mentioned by the public are shown in Figure 28. 


Analysis 

and 

Evaluation 


The public is generally well informed about advances in medical 
research over the past twenty years. However, the public's view 
of these advances differs somewhat from the view of the panel. 


173 


The difference appears to be related to either a degree of 
scepticism on the part of the panel, or a tendency of the pub- 
lic to view advances in medical research as inevitably good. 

A smaller proportion of the public than the panel could 
name past or future advances as having a bad effect on society. 
Where bad effects of advances were mentioned, they were gener- 
ally social in nature (as opposed to effects on health), but the 
public had a greater tendency to believe that the advances 
affected morals unfavorably or were against God or nature. Con- 
versely, the public had a greater tendency to ascribe beneficial 
health effects — particularly increased longevity — to past 
and future advances. 

There was widespread agreement (amounting to near unanimity 
among panelists) that poor and disadvantaged Americans do not 
have equal access to medical advances. The sentiment for 
developing equitable access to advances was strong as indicated 
by the proportions of panelists and public calling for distribu- 
tion of advances according to need or on a f irst-come-f irst- 
served basis. Reinforcing this sense, one-fifth of the public 
felt it was better not to develop advances at all, if they 
cannot be distributed equitably. 

The public’s lack of faith in the way advances were dis- 
tributed did not appear to stem from actions of the medical 
community. Two-thirds of those advocating the establishment 
of rules to govern who should get a new test or treatment were 
willing to allow the medical community to establish those rules. 


174 


application of selected advances 

Findings Testing for and prevention_ ^f_Jjiolence . The public and the 

panel held differing opinions on research on behavior, and the 
application of tests for and the control of violent behavior. 

The majority of the panel (61%) voted for research into new 
ways to change behavior, while the public was less interested 
in this area (43%). However, while the public expressed less 
interest in research into behavior control, they displayed much 
greater interest than the panel in research on tests to deter- 
mine which people are likely to commit violent acts and on the 
applications of such tests and also of technologies to eliminate 
violent crime (Figure 29). 

Overall, 71% of the public favored research into the devel- 
opment of tests to predict violent behavior, compared to 46% 
of the panel. The universal administration of such a test by 
the government was acreed to by 41% of the public, even though 
it might be an invasion of privacy (19% of the panel agreed to 
the same proposition). One-third of the public (but only 7% 
of the panel) were in agreement that the government should make 
everyone likely to commit a violent act take a behavior control 
drug, even if they haven’t committed the act yet. 

A majority of the public (64%) thought that the government 
should make people who have already committed a violent act 
take a drug to prevent them from committing any more, compared 
to 42% of the panel. Ten percent of the public (26% of the 
panel) thought while such people should not be forced to take 
the drug, it should be offered as an alternative to prison; 18% 


175 


of the public (32% of the panel) thought that people who had 
committed violent acts should neither be forced to take a drug 
nor offered such a drug as an alternative to a prison sentence; 
and 8% of the public were not sure on one or both issues. 

A substantial proportion of the public (29%) agreed to 
research on tests which would predict violent acts, mandatory 
testing, and government administration of a behavior control 
drug to prevent the occurrence of a predicted violent act. Few 
panelists (7%) agreed to such a course of action. 

Tests for certain defects . A majority of both the public 
and the panel were in agreement regarding the administration of 
tests for certain defects. There was widespread agreement (72% 
of the public; 93% of the panel) that if a pregnant woman wanted 
a test to tell if her unborn baby had certain defects she should 
have the test even if the government has to pay for it (Figure 
30). 

On the subject of abortion, if a defective fetus were iden— 
tif led, both public and panel were in majority agreement that 
an abortion should be a matter of personal choice (50% of the 
public; 63% of the panel). Nearly one-third of the panel (31%) 
felt a woman should have an abortion, either because taxpayers 
would have to support the child, or because it is wrong to bring 
defective children into the world, compared to 23% of the pub- 
lic. However, the public was more inclined than the panel to 
suggest that a woman should not have an abortion at all because 
it is wrong to destroy any life (21% of the public; 6% of the 
panel) . 


176 


A majority of the public (67%) also agreed with the propo- 
sition that individuals be required to have tests to show if 
they are likely to have children with certain defects prior to 
being given a marriage license. Only a slight majority (51%) 
of panelists agreed with this proposition. Eighty-four percent 
of the public (and 85% of panelists) who agreed to violence 
predictive tests also agreed to required premarital tests. On 
the other hand, while almost all panelists (94%) who disagreed 
with mandatory testing for a tendency to commit violent acts 
also disagreed with required pre-marital testing; only 39% of 
the public did so. 

Select-a-boy, Select-a-girl kit s. Only 19% of the public 
(38% of panelists) said they would use a self-administered 
Select-a-boy > Select-a-girl hit to select the sex of a child, 
were such kits available; 67% of the public (60% of panelists) 
would not do so (Figure 31). 

Panelists almost universally believed that if Select-a-boy y 
Select-a-girl kits were available, people would use them to 
select boys most often (91% said this), and a boy as the first 
child (94% said this). The public was less certain on this 
score: 48% thought boys would be selected more often, and 73% 

thought boys would be selected as the first child. 

If people could select the sex of their children this would 
have a bad effect on society, according to 52% of the public 
(61% of panelists); a good effect according to 12% of the public 

(22% of panelists) ; and no effect according to 20% of the public 

(14% of panelists). Sixteen percent of the public and 3% of pan- 


177 


elists were not sure uhat effect it might have. The most impor- 
tant effect the ability to select the sex of one's child would 
have on society was creation of an imbalance in the sex-ratio 
(Figure 32). Effects mentioned often by those who thought the 
ability to select the sex of children would have a good effect 
on society were: affect the sex ratio (31% of the public; 14% 
of the panelists); limitation of family size (25% of the public; 
but no panelists). 

The majority of the public (55%) and of panelists (62%) 
thought that people should be able to get the Setect^a-boy 3 
Select-a-girl kits (Figure 31). The public, however, was 
less inclined than panelists to allow marketing of the kits 
without a prescription (25% of those favoring availability, 
compared to 56% of panelists of similar persuasion). All of 
the panelists (91% of the public) who thought the ability to 
select the sex of one's children would have a good effect on 
society thought people should be able to get the kits (Figure 33). 
In contrast, 57% of panelists (66% of the public) who thought 
the ability to select the sex of one's children would have a 
very bad effect on society also thought the kits should not be 
available. 

Life and death decisions . A majority of the public (67%) and 
of panelists (88%) thought specific rules should be drawn up to 
decide at what point a person is dead. Of the public and panelists 
who favored such rules, 75% of the public but only 37% of panelists 
thought that researchers, scientists, and doctors should have the 
final say about such rules (Figure 34). Medical scientists favored 


178 


allowing researchers, scientists, and doctors to have final say 
on the rules more than did other panelists (45% vs. 34%). Thir- 
ty-eight percent of panelists thought the government should de- 
cide such rules, but only 6% of the public thought so. 

In the particular example cited in the questionnaire, the 
majority of panelists (57%) felt a special hospital panel con- 
sisting of people such as a doctor, lawyers, and a member of the 
clergy should decide the life and death decision on hand. Only 
a small fraction of the public (12%) chose this option. A plur- 
ality of the public (40%) left the decision to the patienc's 
family and personal physician (compared to 12% of the panel). 
Thirteen percent of the panel (5% of the public) felt that no 
one should decide. 


Analysis 

and 

Evaluation 


The public was considerably more willing than the panel to sacri- 
fice some individual rights in the interest of social benefits. 

In cases where the welfare of society seemed at issue (the pre- 
vention of violent behavior and avoidance of costs of support 
for defective children), the public seemed particularly willing 
to allow suspension of individual rights to privacy or choice. 
However, this principle did not extend to the abortion of a 
defective child, where both the public and the panel favored 
individual freedom of choice. 

Both the public and the panel also favored freedom of 
choice in areas where the welfare of others was not so direct- 
ly at issue (voluntary testing for fetal defects, availability 
of sex selection kits). Still, the panel was generally more 
inclined than the public to allow freedom of choice or access. 


179 


The public also displayed a greater tendency than the panel 
to allow physicians to control access to advances. The public 
wanted to allow researchers, scientists, and doctors to have the 
final say in establishing rules about life and death, and physi- 
cians to control access to sex selection technology through 
prescriptions . 






180 


RULES ABOUT RESEARCH, SAFETY AND EFFICACY OF TESTS A4D TREATMENTS, FINANCIAL 
RESPONSIBILITY FOR TREATMENT 


Findings 

Rules about research, tests, and treatments. According to the 
majority of panelists (72%), at present, there are too few 
rules about the way medical research is done on people, al- 
though the majority of medical scientists (52%) thought there 
were too many rules (compared to only 16% of other panelists 
who held this opinion). The public did not agree on whether 
there are too many or too few rules. Some said there were 
too many rules (15%), some said too few (34%), some thought 
the number was about right (20%), and some were just not sure 


(30%). 

The public and the panel were divided over whether or not 
companies do enough tests to see that a drug is safe and that 

it really works (Figure 35). 

The panel was divided over who should decide when a new 
test or treatment is ready to be used routinely by doctors: 

47% thought it should be researchers, scientists, and doctors; 

37% the government. Medical scientists favored researchers, 
scientists, and doctors more than other four categories of 
panelists (71% to 40%), and not the government (17% to 43%). 

Most of the public (72%), however, favored researchers, scien- 
tists, and doctors. Also, most of the public (87%) and pane- 
lists (82%), thought the government should not prevent anyone 
from having a risky experimental treatment if he/she wants it 
and knows about the risks. 

The majority of the public (68%) and panelists (69%) 
agreed that hospitals should have to tell patients about the 1 


181 


past treatment record of any doctor who will be treating them. 

A majority of medical scientists (63%), however, disagreed 
that this should be done (compared to only 22% of other pane- 
lists; 27% of the public). 

Financial responsibility for treatment . A majority of the 
public (57%) and of panelists (63%) thought that the industry 
causing pollution should be most responsible for the cost of 
illnesses attributed to environmental factors such as pollution 
(Figure 40). Panelists were divided with respect to financial 
responsibility for treating illnesses caused mostly by personal 
habits: 36% of panelists held the person to be mostly responsi- 

ble; 34% of the person’s health insurance plan. A majority of 
the public (62%), however, thought that the person with the ill- 
ness should be responsible, with 19% mentioning the insurance 
plan. Public and panelists were also divided on who should be 
most responsible for the cost of treating illnesses caused 
mostly by a person's inherited make-up; 48% of the public (47% 
of panelists) said the person's health insurance plan, and 30% 
(39% of panelists) the Federal government. A similar division 
obtained regarding responsibility for the cost of treating ill- 
nesses caused mostly by bacteria or viruses. Forty-five percent 
of the public (54% of panelists) thought a person's health insur- 
ance plan should be mostly responsible, while 30% of the public 
(33% of panelists) mentioned the Federal government, although 
medical scientists favored the person's insurance plan by a 
wide margin (78% vs. 48% for other panelists). 

A majority of the public (54%) and of panelists (79%) 


182 


Analysis 

and 

Evaluation 


agreed that people whose personal habits make them more likely 
to get sick should pay more for health insurance. People who 
had never smoked were more likely to agree with the proposition 
than those who smoked regularly (65% vs. 40%). 

The willingness on the part of public and panel to allow those 
who know about the risks to participate in experimental treat- 
ments reinforces the sense that freedom of choice was an impor- 
tant principle when it did not directly conflict with the 
interests of society. In addition, it was apparent that both 
panel and public favored the release of information on physician 
performance, perhaps as a basis for making informed choices. 

The public's faith in researchers, scientists, and doctors 
was underscored again in the willingness to allow them to decide 
when a new test or treatment is ready to be used routinely by 
doctors. Again, this viewpoint was in decided contrast to the 
panel in general. 

There was substantial agreement on the distribution of 
financial responsibility for illness. When agencies or indivi- 
duals were at fault, as in diseases caused by pollution or 
personal habits, responsibility was more frequently assigned 
to that agency or individual. In other cases (diseases caused 
by bacteria, viruses, or inherited diseases) social risk sharing 
mechanisms such as insurance or the government tended to be 


selected. 


183 


RESEARCH 

Findings 


PRIORITIES 

What research should be done . A large majority of the public 
(77%) and panelists (93%) were in favor of government support 
of research to help people take better care of themselves. How- 
ever, the panel and the public were both divided over whether 
more money should be spent to discover new knowledge, or to use 
existing knowledge more completely. Beyond these questions 
there was little correspondence between the panelists' view of 
research priorities and the public's. 

Panelists voted in large majorities for: research toward 

healthy life to age 70, rather than prolonging life past 70 
(95%); basic health care, rather than medical research for new 
tests and treatments (85%); prevention of illness, rather than 
treatment for people when they get sick (81%); and curing those 
who have a chance of becoming healthy, rather than spending on 
care for those who are sick and will never get any better (85%). 
The public's votes on the same questions tended to follow the 
panel's votes, but to give only pluralities or narrow majorities 
where the panel's choices had been overwhelming. In addition, 
the public frequently volunteered "both equally" as the preferred 
option (Figure 37). 

The panel also displayed a clear ranking of research prior- 
ities according to particular types of illness. Panelists felt 
the government should do most research on environmentally caused 
illness, next on illnesses caused by bacteria and viruses, next 
on inherited illnesses, and finally, illnesses caused by personal 
habits (Figure 37). The public agreed with the panel in ranking 


184 


Analysis 

and 

Evaluation 


research into diseases caused by personal habits lowest, but 
the remaining three categories were too close to call. 

Who decides what problems to work on . At present research- 
ers, scientists, and doctors are the groups with the greatest 
influence in deciding what problems medical researchers work on, 
according to 55% of the panelists; 29% thought the government 
had the greatest influence. More medical scientists than other 
categories of panelist thought the government had the biggest 
say (54% vs. 21%). The public was less certain on this score. 
About one- third thought the government had the biggest say; 
another third thought it was largely decided by researchers, 
scientists, and doctors (Figure 38). A majority of the public 
(64%) and of the panelists as a whole (54%) thought that re- 
searchers, scientists, and doctors should have the greatest say 
in deciding what problems medical researchers work on. Medical 
scientists were much more in support of this position than other 
panelists (71% vs. 49%). Finally, 54% of panelists and 49% 
of the public felt medical scientists and researchers were more 
concerned with following their own research interests than with 
doing research that will help the public. 

The public does not appear to have a clear sense of desired 
priorities for medical research, although there is strong inter- 
est in self-assistance technologies, such as do-it-yourself 
tests. The panel, on the other hand, has a very clear sense of 
priorities. This difference is probably attributable to the 
fact that the panel had considerably more information on which 


to base its judgment. 


185 


Even though a majority of the panel and a plurality of 
the public felt that medical scientists were principally con- 
cerned with their own research interests, the majority would 
allow medical scientists and researchers to have the biggest 
say in deciding what problems to work on. This is consistent 
with both the public's confidence in medical scientists and the 
public and panel's views of individual rights. 


186 


VALUE RECEIVED FOR DOLLARS SPENT; FUTURE OUTLOOK 

Findings Value received for dollars spent . In the last 20 years the 

United States has invested $60 billion (in 1975 prices) in 
medical research, $36 billion, coming from the Federal govern- 
ment. Has the public received value for dollars spent? 

According to public and panelists, not only do we get good 
value from medical research paid for by the government (70% of 
the public and 78% of panelists said this) , but the new know- 
ledge, tests and treatments made possible by medical research 
have changed life for the better (94% of the public, 91% of 
panelists said this. Figure 39). Panelists who classified 
themselves as medical scientists agreed more strongly than their 
colleagues that the public gets good value from medical research 
paid for by the government (92% vs. 75%), and that the fruits 
of medical research have changed life for the better. The 
vast majority of panelists (87%) and of the public (87%) thought 
that they or their families have benefited from medical research 
in the last 20 years and that they have significantly improved 
the life of the average person (91% of panelists and 94% of the 
public agreed this was so). 

The public and the panel were divided over whether new 
tests and treatments increase the cost of medical care more than 
they actually benefit people. Forty-seven percent of the 
public felt this w as the case; however, the majority of panelists 
(63%) disagreed with the statement. 

Future outlook. Almost everyone (93% of both panel and 
public) thought that, overall, the new knowledge, tests, and 


187 


Analysis 

and 

Evaluation 


treatments that medical research is likely to come up with in 
the next 20 years will change life for the better, with 49% of 
the public and 19% of panelists believing very much for the 
better . 

The public and the panel agreed that medical research has been 
beneficial and that it will continue to be in the future. The 
public particularly was optimistic about the benefits. However, 
the public tended to be slightly more skeptical than the panel 
about the benefits of new tests and treatments in relationship 


to their costs. 


188 


Figure 18 

NEW TESTS, TREATMENTS, OR NEW KNOWLEDGE MADE POSSIBLE IN THE LAST 20 YEARS 
MENTIONED BY THE GENERAL PUBLIC (1) 



Prevention, treatment of cancer 56 

Prevention of infectious diseases A3 

Organ transplantation, by-pass surgery, radical surgery .... 27 

Prevention, treatment of heart disease, other than surgery . 11 


Life-extending equipment, artificial life support organs ... 7 

Treatment for mental illness 7 

Improved contraception 6 

Treatment for infectious diseases 6 

Prevention of birth defects, screening for genetic disease . 5 

Diagnostic equipment, CAT-scanner, autoanalyzer, etc 5 


(1) Classes mentioned by at least 5% of those mentioning an item. 

77% of the general public could think of at least one new test or 
treatment or item of new knowledge; the remainder (23%) answered 
"not sure", "none, nothing", or did not respond to the question 
(wN=l, 307) . 

(2) Since up to three mentions were possible, the column does not sum 
to 100%. 


189 


Figure 19 

ACCESS TO NEW TESTS AND TREATMENTS 


Question 




Do you chink all types of Americans Yes 9 32 

can equally gee the new tests and No 91 60 

treatments made possible by medical Not sure * 0 8 

research, or not? 


What cypes of Americans can get Poor, disadvantages (1) 99 67 

less of Che new cescs and treatments. Rural population 31 3 

even when chey need chem? Ethnic, racial minorities 16 3 

Middle class people 10 13 


When a new test or treatment first People who can pay for ic? 60 56 

comes out, there is somecimes not People who know an important doctor 

enough for everyone who needs it. or other person? 26 16 

Today, who is mosc likely to get People who apply for it first? .... 5 15 

a new test or treatment? Is it: Those who need ic the nose * 6 8 

Ocher classes of people * 0 3 

Combinations of the above * 1 1 

Not sure * 3 3 


Today, do you think any rules have Yes (2) (3) 67 

been set up to decide which people No 25 

mosc need a new test or treatment? Not sure * 28 


Today, who do you think has the The government (6) (3) 28 

final say when it comes to setting Researchers, scientists, and 

up chese rules? doctors 58 

The company that developed the new 

test or treatment 3 

Citizens' groups, someone else .... 6 

Combinations of the above * 2 

Not sure * 5 


Who do you chink should get a new People who can pay for it? 2 5 

test or treatment, it there is not Or people who know an important 

enough for everyone who needs it? doctor or other person? 1 2 

Should it be: Or people who apply for ic first? . 20 38 

Those who need it the mosc * 62 67 

Ocher classes of people * 10 5 

Combinations of the above * 2 1 

Not sure * .. 6 2 


Do you chink rules should be set Yes (2) (3) 70 

up to decide which people most need No, 20 

a new test or treatment? Not sure * 11 


Who do you chink should have the The government (6) (3) 9 

final say when it comes to setting Researchers, scientists and doctors 66 

up chese rules? The company that developed the new 

test or treatment 5 

Citizens' groups, someone else .... 12 

Combinations of the above * 6 

Not sure * 6 


If new tests and treatments cannot Agree 7 21 

be made available to all who need Disagree 93 78 

them, it is better not to develop Not sure * 0 1 

them at all. 


* Volunteered response 

(1) Percentage of respondents who answered "no" to preceding question. Because 
multiple responses were possible answers do not sum to 100’;. Responses were 
open-ended . 

(2) Percentage of respondents who answered "those who need it" in preceding 
question. 

(3) Because the trigger response was volur.tered it was not possible to include 
this question in the sel f-administered version of the questionnaire sent 
to panelists. 

(4) Percentage of respondents who answered "yes" in preceding question. 


190 


Figure 20 

NEW TEST OR TREATMENT OR NEW KNOWLEDGE MADE POSSIBLE IN THE LAST 20 YEARS THAT 
HAD THE GREATEST GOOD EFFECT ON SOCIETY (1), AND THEIR EFFECTS (2) 



(1) Classes mentioned by at least 5% of those mentioning an item. 100 of the 107 
panelists who completed this part of the PEI (93%) mentioned a specific item; 

3% answered "not sure"; 4% did not respond to the question (N=100) . Of the 77% 
of the general public who could think of a new test or treatment or item of new 
knowledge, 92% mentioned a specific item; the remainder (8%) answered "not sure", 
"none, nothing"; or did not respond to the question (wd=l,204). 

(2) Effects of all tests, treatments, or new knowledge mentioned as having had the 
greatest good effect on society in the last 20 years. 

(3) Since up to three mentions were possible, columns do not sum to 100%. 




191 


Figure 21 

EFFECT MENTIONED FOR EACH CLASS OF NEW TEST, TREATMENT, OR KNOWLEDGE THAT HAD 
THE GREATEST GOOD EFFECT ON SOCIETY IN THE LAST 20 YEARS. (Percentage of 
the general public nentioning the effect) 




373 

314 

139 

75 

46 

45 

33 

Economic effects 

3 

2 

9 

7 

4 

2 

12 

Ethical effects 

0 

0 

0 

0 

6 

0 

0 

Decreased morbidity, physical 
and mental 

87 

60 

29 

47 

4 

77 

32 

Increased morbidity, physical 
and mental 

1 

0 

1 

4 

0 

0 

12 

Increased longevity 

17 

43 

80 

51 

2 

34 

0 

Decreased stigma, fear, anxiety, 
labelling 

15 

8 

6 

3 

0 

2 

6 

Increased utilization 

1 

0 

0 

0 

5 

0 

0 

Other health effects 

2 

20 

1 

21 

2 

0 

33 

Increased quality of life 

9 

21 

20 

23 

2 

14 

15 

Other effects on individuals .... 

1 

i 

1 

1 

4 

0 

10 

Legal effects 

0 

0 

0 

1 

0 

0 

0 

Controlled, limited population, 
family size . ... ; 

0 

0 

0 

0 

88 

0 

0 

Other social effects 

0 

0 

0 

0 

7 

0 

6 

Technical effects 

1 

6 

1 

4 

0 

5 

14 

Environmental and other effects . 

1 

3 

0 

3 

0 

0 

0 


(1) Classes mentioned by at least 3% of the public mentioning an item. Of the 77% of the 
general public who could think of a new test or treatment or item of new knowledge, 

92% mentioned a specific item; the remainder, 8%, answered "not sure", "none, nothing", 
or did not respond to the question (wN=l,204). "N" indicates the number of respondents 

who mentioned the particular advance. 

(2) Classes and subclasses of effects mentioned by at least 5% of the public naming a 
specific item as having had the worst effect on society. 

(3) Since up to three mentions were possible, columns do not sum to 100%. 


192 


Figure 22 

NEW TESTS, TREATMENTS, OR NEW KNOWLEDGE MADE POSSIBLE IN THE LAST 20 YEARS THAT 
HAS HAD THE WORST EFFECT ON SOCIETY (1), AND THEIR EFFECTS (2) 



— less than 1%. 

(1) Classes of new tests, treatments, or new knowledge mentioned by at least 5% of 
those mentioning an item. 82 of the 107 panelists who completed this part of 
the PEI (77%) mentioned a specific item; 10% answered "none, nothing", "don't 
know"; 13% did not respond to the question (N=82). Of the 77% of the general 
public who could think of a new test or treatment or item of new knowledge, 

48% mentioned a specific item; the remainder (52%) answered "not sure", "none, 
nothing", or did not respond to the question (wN=653) . 

(2) Effects of all tests, treatments, or new knowledge mentioned as having had the 
worst effect on society in the last 20 years. 

(3) Since up to three mentions were possible, columns do not sum to 100%. 




193 


Figure 23 

EFFECTS MENTIONED FOR EACH CLASS OF NEW TEST, TREATMENT, OR KNOWLEDGE THAT 
HAD THE WORST EFFECT ON SOCIETY IN THE LAST 20 YEARS (Percentage of the 
general public nentioning the effect) 



iV= ISO 120 SO 54 

Increased economic hardship, 

poverty 0 10 1 

Increased health care costs 0 1 7 7 

Other economic effects 0 1 4 4 

Morals unfavorably affected 41 2 0 0 

Against God, nature 10 0 0 

Other ethical effects 13 4 0 2 

Decreased morbidity, physical 

and mental 112 6 

Increased morbidity, physical 

and cental 14 8 42 

Decreased longevity 0 2 1 1 

Increased stigma, fear, anxiety, 

labelling 0 2 5 24 

Increased utilization 61 38 46 43 

Other health effects 2 5 6 14 

Decreased quality of life 0 14 3 

Created false hopes, expectations 0014 

Other effects on individuals .... 2 24 5 

Legal effects 0 110 

Increased crime, deviance, 

violence 1 17 0 0 

Increased drug, alcohol 

addiction 3 41 1 0 

Other social effects 8 2 2 0 

Technical effects 1 5 20 24 

Environmental and other effects ,211 


45 

27 

2 

2 

0 

10 

18 


0 

2 

3 

13 

3 
40 

2 

4 
0 


34 24 23 20 

0 0 0 0 

0 0 4 58 

2 0 0 16 

0 0 0 0 

0 13 0 6 

2 12 0 0 

3 0 0 0 

31 0 4 0 

3 8 4 5 


8 

19 

6 

3 

0 

7 

5 


3 

0 

3 

45 


8 

29 

36 

7 

8 
4 
0 


0 

0 

12 

3 


14 
59 

15 
0 
0 
0 
4 


0 

0 

17 

0 


6 

11 

5 

7 

0 

0 

0 


0 

0 

27 

0 


(1) Classes mentioned by at least 3% of the public mentioning an item. Of the 77% of the 
general public who could think of a new test or treatment or item of new knowledge, 

43% mentioned a specific item; the remainder, 52%, answered "not sure", "none, nothing”, 
or did not respond to the question (wN-653). "N" indicates the number of respondents 

who mentioned the particular advance. 

(2) Classes and subclasses of effects mentioned by at least 5% of the public naming a 
specific item as having had the worst effect on society. 


(3) Since up to three mentions were possible, columns do not sum to 100%. 


194 


Figure 24 

NEW THINGS CONSULTANT PANELISTS AND THE GENERAL PUBLIC WANTED MEDICAL SCIENCE 
TO COME UP WITH IN THE NEXT 20 YEARS (1) 


New test, treatment, knowledge 

Prevention, treatment of cancer 59 

Prevention, treatment of heart disease, other than 

surgery 36 

Treatment for mental illness 23 

Control of pollution, environmental hazards; prevention 
of environmentally caused disease 20 

Improved health services, availability, accessibility .... 13 

Control of violent behavior; aggression 13 


Prevention of aging, senility; prolongation of healthy life 13 


Health education, knowledge . 10 

Improved contraception . 9 


Prevention of birth defects, screening for genetic disease 9 


Treatment of infectious diseases 5 

National health policy, various aspects 5 

Prevention, treatment of arthritis 1 

Prevention, treatment of muscular dystrophy 1 

Prevention, treatment of diabetes 0 


73 

26 

14 

8 

3 

2 

3 

4 
3 
7 

7 
2 

8 
6 

10 



(1) Class mentioned by at least 5% of those mentioning an item. 

104 of the 107 panelists who completed this item (97%) mentioned a 
specific item; the remainder (3%) did not respond to the question 
(N=104) . 90% of the general public mentioned a new test or treatment 

or item of new knowledge; the remainder (10%) answered "not sure", 
"none, nothing", or did not respond to the question (wN=l,526). 

(2) Since up to three mentions were possible, columns do not sum to 100%. 


195 


Figure 25 

NEW THING THAT WILL HAVE GREATEST GOOD EFFECT ON SOCIETY, IN THE NEXT 20 YEARS 
(1), AND THEIR EFFECTS (2) 



Prevention, treatment of cancer . 
Nonspecific treatment of cancer . 

Health education, knowledge ..... 
Education of the public about 
diet 

Improved health services, access, 
availability 

Control of pollution, environ- 
mental hazards; prevention of 
environmentally caused disease . . 


15 

11 

11 

4 


52 

48 

3 

3 


Decrease morbidity, physical 
and mental 


39 


Increase quality of life 15 

Increase longevity 14 

Other economic effects 10 

Decrease stigma, fear, anxiety, 
labelling 10 


Other health effects 


10 


40 

21 

31 

8 

17 

4 


Improved contraception 9 1 

Prevention, treatment of heart • 

disease, other than surgery 8 5 

Treatment for mental illness .... 6 7 

Prevention of birth defects, 

screening for genetic disease ... 3 2 

Treatment of infectious diseases 3 2 

All other classes 

(each mentioned by 3% or less of 

panelists; 2% or less of the 

general public 27 20 


Total 100 100 


Technical effects 8 3 

Control, limit population, family 

size 8 1 

Other social effects 8 4 

Other effects on individuals 5 7 

Political effects 5 

Environmental and other effects ... 1 6 

Decrease health care costs 0 6 


less than 1%. 

(1) Classes mentioned by at least 5% of those mentioning an item. 98 of the 107 
panelists who completed this part of the PEI (92%) mentioned a specific item; 

1% answered "none, nothing", 7% did not respond to the question (N=98). Of the 
90% of the general public who could think of a new test or treatment or item of 
new knowledge they wanted medical science to come up with, 88% mentioned a 
specific item; the remainder (12%) answered "not sure", "none, nothing", or 
did not respond to the question (wN=l,340). 

(2) Effects of all new tests, treatments, or new knowledge mentioned that will 
have the greatest good effect on society. 

(3) Since up to three mentions were possible, columns do not sum to 100%. 


196 


Figure 26 


EFFECTS MENTIONED FOR EACH CLASS OF NEW TEST, TREATMENT, OR KNOWLEDGE THAT 
WILL HAVE THE GREATEST GOOD EFFECT ON SOCIETY IN THE NEXT 20 YEARS 
(Percentage of the general public mentioning the effect) 


New test, treatment, knowledge (1) 


Effect (2) (3) 



N= 

Decrease health care costs 

Other economic effects 

Decrease morbidity, physical and 
mental 

Increase longevity 

Decrease stigma, fear, anxiety, 
labelling 

Other health effects . „ 

Increase quality of life 

Other effects on individuals .... 

Decrease crime, deviance, 
violence 

Other social effects 

Environmental and. other effects . 


699 

91 

79 

69 

40 

6 

3 

5 

1 

5 

3 

13 

2 

7 

10 

36 

19 

64 

42 

54 

45 

7 

17 

45 

9 

28 

5 

0 

11 

0 

3 

6 

4 

4 

13 

15 

31 

13 

31 

22 

6 

20 

4 

5 

10 

-- 

35 

2 

0 

8 

— 

2 

0 

0 

0 

5 

9 

28 

4 

9 


— less than 1% 


(1) Classes mentioned by at least 3% of the public mentioning an item. One of 

90% of the general public who could think of a new test or treatment or 

item of new knowledge they wanted medical science to come up with, 88% 
mentioned a specific item; the remainder, 12%, answered "not sure", 

"none, nothing", or did not respond to the question (wN=l,340). "N" 

indicates the number of respondents who mentioned the particular advance. 

(2) Classes and subclasses of effects mentioned by at least 5% of the public 

naming a specific item as having had the worst effect on society. 

(3) Since up to three mentions were possible, columns do not sum to 100%. 




197 


Figure 27 

NEW THINGS THAT WILL HAVE WORST EFFECT ON SOCIETY IN NEXT 20 YEARS (1), AND 
THEIR EFFECTS (2) 


New Test, Treatment, Knowledge 


Control of behavior 

Nonspecific control of behavior . 

Life-extending equipment; artifi- 


cial life support organs 15 

Knowledge of genetics, gene man- 
ipulation 13 

Manipulation of gems, genetic 
engineering 8 

Pollution, environmental hazards 9 

Mar, biological weapons 5 

Pollution 4 

Treatment for mental illness .... 9 

Proliferation of tranquilizers .. 9 

High cost of care, poor health. 

care 8 

Selection of sex of offspring ... 4 

Improved contraception 0 

Insufficient testing of drugs ... 0 

National health policy, various 
aspects 3 

All other classes 
(each mentioned by 2% or less of 
panelists, 3 % or less of the 
general public) 16 

Total 100 


the state, special 


4 


Environmental effects 


11 

9 

1 

4 

14 

11 

4 

13 

8 

4 

4 

26 


Other ethical effects 

Increase morbidity, physical and 
mental 

Increase dependency, lower self- 
esteem 

Other social effects 

Decrease quality of life 

Technical effects 

Other health effects 

Other effects on individuals ... 

Increase genetic regulation .... 

Increase utilization of drugs, 
services 

Create false hopes, expectations 

Other economic effects 

Against God, nature 

Affect the sex ratio 


100 


Increase health care costs 



16 11 

16 11 

15 6 

13 14 

11 

10 12 

9 3 

9 3 

9 10 

8 7 

6 5 

5 15 

5 0 

1 11 

0 7 

1 6 

0 5 



less than 1%. 

(1) Classes mentioned by at least 5% of those mentioning an item. 79 of the 107 
panelists who completed this part of the PEI (74%) mentioned a specific item; 

8% answered "none, nothing" or "don't know"; 18% did not respond to the 
question (N=79). Of the 90% of the general public who could think of a new test 
or treatment or item of new knowledge they wanted medical science to come up 
with, 40% mentioned a specific item, the remainder (60%) answered "not sure", 
"none, nothing", or did not respond to the question (wN=604) . 

(2) Effects of all new tests, treatments, or new knowledge mentioned that will have 
the worst effect on society. 

(3) Since up to three mentions were possible, columns do not sum to 100%. 


198 


Figure 28 

EFFECTS MENTIONED FOR EACH CLASS OF NEW TEST, TREATMENT, OR KNOWLEDGE THAT WILL 
HAVE THE WORST EFFECT ON SOCIETY IN THE NEXT 20 YEARS (Percentage of the 
general public mentioning the effect) 


New test, treatment, knowledge (1) 


Effect (2) (3) 

N= 87 

Increase economic hardship, 

poverty , . * . . . . . 0 

Increase health care costs 1 

Other economic effects 0 

Morals unfavorably affected 1 

Against God, nature 0 

Increase genetic regulation 1 

Other ethical effects .....o 4 

Increase morbidity, physical 

and mental 16 

Decrease longevity 3 

Increase stigma, fear, anxeity, 
labelling . . . . . 0 

Increase utilization 23 

Other health effects . . 5 

Effects on individuals 15 

Domination by the state, special 
interes ts 16 

All other political effects 0 

Increase crime, deviance, violence 15 

Affect the sex-ratio 0 

Other social effects 2 

Technical effects 0 

Environmental and other effects . 2 


81 66 52 

0 0 0 

12 0 

2 0 0 

2 4 2 

31 14 0 

8 30 0 

6 4 0 

0 3 45 

0 0 8 

10 2 

3 14 0 

0 0 5 

16 4 

4 33 2 

0 2 0 

2 0 1 

41 3 0 

5 12 2 

0 0 0 

6 1 34 


48 27 26 

2 12 4 

2 30 0 

4 15 4 

12 0 0 

4 0 4 

0 0 0 

0 4 0 

22 15 14 

3 0 4 

2 4 6 

24 7 73 

0 16 4 

12 4 4 

0 0 0 

0 0 0 

5 0 0 

0 0 0 

8 0 0 

3 6 0 

12 4 3 


25 24 

0 0 

9 0 

19 0 

0 4 

0 8 

0 0 

13 0 

4 4 

0 0 

12 8 

3 4 

8 25 

10 17 

36 0 

0 0 

4 0 

0 0 

0 17 

15 8 

8 17 



(1) Classes mentioned by at least 3% of the public mentioning an item. Of the 90% of the 
general public who could think of a new test or treatment or item of new knowledge they 
wanted medical science to come up with, 40% mentioned a specific item; the remainder, 
60%, answered "not sure", "none, nothing", or did not respond to the question (v:>604). 
"N" indicates the number of respondents who mentioned the particular advance. 

(2) Classes and subclasses of effects mentioned by at least 5% of the public namin’ a 
specific item as having had the worst effect on society. 

(3) Since up to three mentions were possible, columns do not sum to 100 . 


199 


Figure 29 

TESTS FOR VIOLENT ACTS: USE OF DRUGS TO PREVENT VIOLENT ACTS 



Research should be done to develop 
tests to find out which people are 
likely to commit violent acts such 
as murder or rape. 


A § ree 46 

Disagree 54 

Not sure * n 


Suppose a test existed that could 

ff a person is likely to commit 
a violent act, such as murder or 
rape. Even though it might be an 
invasion of privacy to make every- 
one take such a test, the govern- 
ment should make everyone take it 
in order to protect people from 
violent acts. 

If a drug to control violent behav- 
ior existed, the government should 
make everyone who has committed a 
violent act, such as murder or rape, 
take the drug to prevent them from 
committing any more violent acts. 


Agree ig 

Disagree 8l 

Not sure * n 


71 

22 

8 


41 

57 

8 


The government should make everyone 
who is likely to commit a violent 
act, such as murder or rape, take 
such a drug, even if they haven't 
committed the act yet, to make 
sure that they don't. 


The government should offer such a 
drug to a person who has committed 
a violent act, such as murder or 
rape, as an alternative to a 
prison sentence. 


Agree 41 

Disagree 5g 

Not sure * q 

Agree ? 

Disagree g3 

Not sure * q 

Agree 5g 

Disagree 

Not sure * q 


66 

28 

7 


33 

56 

10 


39 

50 

11 


Volunteered response 


200 


Figure 30 

TESTS FOR CERTAIN DEFECTS 



Before being given a marriage license, 
individuals should be required to 
have these tests. 


As you may know, there is a test that 
a doctor can do to tell if an unborn 
baby has certain defects. If a preg- 
nant woman wants such a test, when 
should she have it, if at all? 


Only if she can pay for it herself. 4 12 

Even if she can't pay for it her- 
self and the government has to 

pay for it 93 72 

Or, shouldn't she have it at all ..4 9 

Not sure * 0 


Jane Doe has had this test. It 
showed that if the baby were born it 
would have serious defects that would 
require life-long care. Since Jane 
Doe could not pay for this life-long 
care herself, the government would 
have to pay for it. What should be 
done? 


She should have an abortion, because 
taxpayers would have to support 

the child 8 

She should have an abortion no 

matter who would pay for the care 
of the child, because it is wrong 


to bring children with serious 

defects into the world 23 

She should have an abortion only 
if she wants one, because it is 

a matter of personal choice 63 

She should not have an abortion at 
all, because it is wrong to 

destroy any life 6 

Not sure * 1 


6 

17 

30 

21 

5 


* Volunteered response 


201 


Figure 31 

SELECT-A-BOY, SELECT-A-GIRL MARKETABLE KITS 



Suppose a company has developed a safe medical product which people can 
use when they want to select a boy or a girl baby. These "select-a-boy" 
and "select-a-girl" kits would be used before the woman gets pregnant. 
The kits would be sold through drug stores. 


If you wanted to have a child and Yes 38 19 

these kits were available, would you No 60 67 

use one? Not going to have any children (1) 0 6 

Not sure * 2 8 


If these kits were available, do Boys , ... 91 48 

you think people would use them to Girls 1 3 

select boys more often or to select Both equally * 5 19 

girls? People wouldn't use them * 0 5 

Not sure * 3 23 


If these kits were available, do Boys 94 73 

you think people would select a boy Girls ....<, 2 3 

or a girl for their first child? Both equally * 3 7 

People wouldn't use them * 0 3 

Not sure * 1 14 


If people could select the sex of A good effect? 22 12 

their children, what effect do you A somewhat bad effect? 35 25 

think this would have on society, A very bad effect? 26 27 

i.e. people in general, and not just Or, would it have no effect at all? 14 20 

the people who would use the kits? Not sure * 3 16 

Would it have: 


Now, do you think people should be Without a prescription 38 14 

able to get these kits? Only if prescribed by a doctor .... 30 41 

Or, not at all 32 38 

Not sure * 0 6 


* Volunteered response 

(1) This response almost exclusively confined to people aged 45 years and older 


202 


Figure 32 


MOST IMPORTANT EFFECT THAT ABILITY TO SELECT THE SEX OF CHILDREN WOULD HAVE ON 
SOCIETY, ACCORDING TO VIEW OF EFFECT (1) (2) 


Effects mentioned by those who 
thought that ability to select 
the sex of children would have 
— a good effect on society 



Effects mentioned by those who 
thought that ability to select 
the sex of children would have 
— a bad effect on society 



Control, limit population, family 



Affect the sex ratio 


64 

size 

50 

25 







Other social effects .... 


10 

Affect the sex-ratio 

14 

31 







Against God, nature 


22 

Other individual effects 

14 

10 







Other effects on individuals 2 

7 

Other social effects 

14 

6 







All other effects 



Increase quality of life 

0 

25 

(each mentioned by only 1 

panelist; 





3% or less of the general 

public) . 3 

10 

All other effects 






(each mentioned by only 1 pane- 






list; 1% or less of the general 






public ) 

9 

7 




(1) 22% of panelists responded "a 

good 

effect"; 61% "a bad effect"; and 

14% "no effect"; 



3% responded "don't know". 


(2) 12% of the general public responded "a good effect"; 51% "a bad effect"; 20% "no 
effect"; 17% responded "don't know", or did not respond to the question. 

(3) Since more than one mention was possible columns do not sum to 100%. 

Figure 33 

APPROPRIATE DISTRIBUTION OF SELECT-A-BOY , SELECT-A-GIRL KITS, BY EFFECT OF THE 
KITS ON SOCIETY 



(1) "N" indicates the number of panelists or public who mentioned this effect. 


203 


Figure 34 


LIFE AND DEATH DECISIONS 



A person , John Doe, is being kept alive by a machine. He is unconscious , 
in a coma. Doctors think that he is close to death and that he has no 
chance of recovery. Another person, David Smith, will die if not put on 
the machine. Doctors think tJiat if David Smith is put on the machine he 
has an excellent chance of recovery . 


: 


The problem is that the hospital has only the one machine and there isn't 
time to get another one. 


Who, if anyone, should decide if 
John Doe should be taken off the 
machine in order to give it to 
David Smith? 


No-one, John Doe should stay on 

the machine until he dies 13 5 

John Doe's personal doctor 1 6 

John Doe's family only 0 13 

John Doe's family and his personal 

doctor 12 40 

The hospital doctor in charge of 

the machine 3 3 

A special hospital panel consisting 

only of doctors 7 9 

A special hospital panel consisting 
of people, such as a doctor, 

lawyer, and member of the clergy 57 12 

The local courts 2 2 

Someone else * 7 3 

Not sure * 2 6 


As you may know, in a few cases when Yes 

someone is being kept alive by medi- No 

cal equipment, it is difficult to Not sure * 

determine if the person is alive or 

dead. Do you think specific rules 

should be drawn up to decide at what 

point a person is dead? 


88 67 

12 18 

0 14 


Who do you think should have the 
final say as to what the rules 
should be? Should it be: 


The government? ( 1 ) 33 

Researchers, scientists, and 

doctors? 37 

Citizens' groups, someone else? ... 5 

Combinations of the above * 19 

Not sure * 1 


6 

75 

11 

5 

3 


* Volunteered response 

( 1 ) Percentage of respondents who answered "yes" to the preceding question 


I 



204 



Figure 35 

RULES ABOUT RESEARCH, APPLICATION OF 

TECHNOLOGIES 




/Response 

/ .9 
/ o" . e V / 

/ "V ft? p 

h § * z 

/O ‘t, 

At present, do you think there are 
too many rules, or too few rules 


24 

15 

iuo many tmco • •• •• •• •• » 

72 

34 


2 

20 

about the way medical research is 

Just about tne ngiiL llulllucl 

2 

0 

done on people. 

wrong ruitb 

0 

30 





Before a drug is used routinely. 


52 

58 


48 

35 

companies do enough tests to see 
that the drug is safe and that it 
really works. 


0 

6 




The government shouldn't prevent 


82 

87 


18 

8 


mental treatment if they want it. 


Not sure * 


Who do you think should decide when 
a new test or treatment is ready to 
be used routinely by doctors? Should 
it be : 


The government? 

Researchers, scientists, and 

doctors? 

The company that developed the new 

test or treatment? 

Citizens' groups, someone else? ... 

Combinations of the above * 

Not sure * 


47 

0 

7 

9 

1 


know about rue 

Hospitals should have to tell 

— 

69 

68 


31 

27 

patients about the past treatment 
record of any doctor who will be 


0 

5 




treating them. 



1 *) 


72 

7 

4 

2 

2 


* Volunteered response 


205 


Figure 36 

FINANCIAL RESPONSIBILITY FOR TREATMENT 


Question 


Response 


Some illnesses seem to be caused 
mostly by environmental factors 
such as pollution. Who should be 
mostly responsible for paying the 
cost of treating such illnesses? 


The person with the illness? 

the person s health insurance 

plan? 

Or the government? 

Or the industry causing the 

pollution? 

Someone else * 

Combinations of the above * 

Not sure * . 


Some illnesses seem to be caused 
mostly by personal habits such as 
smoking or drinking. Who should be 
mostly responsible for paying 
the cost of treating such illnesses? 


Some illnesses such as diabetes, 
sickle cell anemia, and hemophilia, 
seem to be caused by a person’s 
inherited make-up. Who should be 
mostly responsible for paying the 
cost of treating such illnesses? 


The person with the illness? 

Or the person’s health insurance' 

plan? 

Or the government? 

Someone else * 

Combinations of the above * 

Not sure * . . 


Some illnesses such as measles, 
influenza, and tuberculosis seem to 
be caused mostly by bacteria and 
viruses. Who should be mostly 
responsible for payint the cost of 
treating such illnesses? 

People whose personal habits (such 
as smoking or drinking) make them 
more likely to get sick should pay 
more for health insurance. 


The person with the illness? 

Or the person's health insurance' 

plan? 

Or the government? 

Someone else * 

Combinations of the above * 

Not sure 

Agree 

Disagree . . 

Not sure * 



The person with the illness? 

Or the person’s health insurance 

plan? 

Or the government? 

Or the company making the product* 
such as cigarettes or alcoholic’ 

drinks? 

Someone else * 

Combinations of the above * ' 

Not sure * .... 


2 

4 

11 

11 

16 

22 

63 

57 

8 

— 

0 

3 

0 

3 

36 

62 

34 

19 

10 

7 

16 

8 


<47 

39 

7 

4 

0 


54 

35 

3 

2 

1 

79 

22 

0 


14 

48 

30 

2 

2 

4 


19 

45 

30 

1 

2 

3 

54 

40 

6 


— less than 1% 


Volunteered 


response 


206 


Figure 37 

RESEARCH PRIORITIES 


Question 




The government should support re- Agree 93 77 

search to help people take better Disagree 8 19 

care of themselves, such as develop- Not sure * 0 4 

ing do-it-yourself tests to see 
if they have certain illnesses. 


On which should the government spend Healthy life to 70 95 57 

more money: to make sure everyone Prolong life past 70 5 21 

can lead a more healthy life until Both equally * 0 18 

the age of 70, £r to prolong life Not sure * 0 4 

past the age of 70? 


On which should the government spend To discover new knowledge 51 40 

more money: to discover new know- To use what we have 49 33 

ledge, tests, and treatments, or to Both equally * 1 23 

use the knowledge, tests, and Not sure * 0 4 

treatments we already have more 
completely? 


On which should the government spend Basic health care 85 41 

more money: to spend money so that Support medical research 14 30 

everyone can get basic health care Both equally * 1 25 

or to spend money on medical research Not sure * 0 4 

so that new and better tests and 
treatments can be found for serious 
illnesses that do not affect 
everyone? 


On which should the government spend Keep healthy, prevent illness 81 58 

more money: to try and keep every- Treat those who get sick 18 18 

one healthy and prevent them from Both equally * 1 22 

becoming ill op to treat people when Not sure * 0 2 

they get sick? 


On which should the government spend Cure sick people with a chance .... 85 60 

more money: to cure sick people Care for sick who will not get 

with some chance of being healthy better 12 4 

again op to care for people who are Both equally * 2 31 

sick and will never get any better? Don't know * 2 5 


In order to improve the health, of the average person , the government can 

emphasize any of four types of medical research: 

1. research on illnesses that are mostly caused by personal habits (such 
as smoking and lung earner; and heavy drinking and liver disease ) ; 

2. research on illnesses that are mostly caused by an individual's 
inherited make-up (such as diabetes, sickle-cell anemia , and 
hemophilia) ; 

3. research on illnesses that are mostly caused by bacteria or viruses 
(such as measles and tuberculosis ) ; and 

4. research on illnesses that are mostly caused by things in the environ- 
ment (such as air pollution and lung disease). 

Mean Rank Score (1 


Which type of medical research do 7. Personal habits 3.3 3.1 

you think the government should 2. Inherited make-up 2.9 2.1 

do most? 3. Bacteria and viruses 2.1 2.3 

4. Environment 1.7 2.4 


* Volunteered response 

(1) Product of the sura of the ranks divides by number of responses: 1 is highest 

priority . 


207 


Figure 38 

DECISION-MAKING WITH RESPECT TO RESEARCH 



In deciding what research to do. Agree 54 49 

most medical scientists and research- Disagree 46 35 

ers are more concerned with following Not sure * „ 0 15 


their own research interests than 
with doing research, that will help 
the public. 


At present, what group do you think The government? 29 34 

has the biggest say in deciding what Researchers, scientists, and 

problems medical researchers work doctors? 55 32 

on. Is it: Private industry, such as drug 

companies? 12 18 

Citizens' groups, someone else? ... 0 3 

Combinations of the above * 5 1 

Not sure * <, 0 12 


What group do you think should have The government? 21 12 

the biggest say in deciding what Researchers, scientists, and 

problems medical researchers work doctors? 54 64 

on? Should it be: Private industry, such as drug 

companies? 0 2 

Citizens' groups, someone else? ... 8 14 

Combinations of the above * 16 3 

Hot sure * 2 5 


* Volunteered response 


208 


Figure 39 


VALUE RECEIVED FOR DOLLARS SPENT; FUTURE OUTLOOK 



Overall, do you think that the new Very much for the better 33 59 

knowledge, tests, and treatments Somewhat for the better 64 34 

made possible by medical research For the worse 2 2 

have changed life very much for the Both for the better and for the 

better, somewhat for the better, worse * 0 3 

somewhat for the worse, or very Had no effect * 0 1 

much for the worse? Not sure * 1 1 


Do ybu think you or your family have Yes 87 87 

benefitted from the new knowledge. No . 13 13 

tests, and treatments made possible 
by medical research in the last 20 
years? 


New knowledge, tests, and treatments Agree 91 94 

made possible by medical research Disagree 9 4 

have significantly improved the Not sure * 0 

life of the average person. 


In general, the public gets good Agree 78 70 

value from medical research paid Disagree 21 19 

for by the government. Not sure * 1 11 


Agree 38 

Disagree 63 

Not sure * 0 


New tests and treatments made 
possible by medical research increase 
the cost of medical care much more 
than they actually benefit the 
people who get them. 


Overall, do you think that the new 
knowledge, tests, and treatments 
that medical research is likely to 
come up with in the next 20 years 
will change life very much for the 
better, somewhat for the better, 
somewhat for the worse, or very 
much for the worse? 


Very much for the better 19 

Somewhat for the better 74 

For the worse 6 

Both for the better and for the 

worse o 

Will have no effect 0 

Not sure * j 


* Volunteered response 


47 

38 

16 


49 

44 

2 

3 

0 

2 


209 


Appendix 1: 
Methods 


211 


INTRODUCTION 


Study 

Objectives 


Study 

Methods 


This special study was mandated by the U.S. Congress under 
Section 203 of PL 93-348, The National Research Act. It was 
conducted under contract N01-HU-6-2105 for the National Commis- 
sion for the Protection of Human Subjects of Biomedical and 
Behavioral Research. 


The objectives of the study were: 

* to identify a limited number of subject areas and 
advances in biomedical and behavioral research and 
services within each subject area that will probably 
take place in the next 20 years, quintessential 
examples, to act as foci of inquiry; 

* to identify foreseen implications of these quintes- 
sential advances in biomedical and behavioral research 
and services, and appropriate policies to respond to 
them; 

* to examine the implications of policies that might be 
implemented with respect to selected, quintessential, 
technological advances in biomedical and behavioral 
research; 

* to evaluate certain general policies that may be used 
to control or direct certain aspects of biomedical 
and behavioral research and the implementation of 
resultant technologies; 

* to examine the consequences of a possible national 
policy that might be adopted with respect to biomedi- 
cal and behavioral research and the implementation of 
resultant technologies; and 

* to analyze and evaluate public understanding of and 
attitude toward advances in biomedical and behavioral 
research, technology, and services and their effects, 
the use of technology in medical practice, and policies 
pertinent to the entire subject of study. 


In order to accomplish the special study objectives two inte- 
grated inquiries were designed and implemented. They were: (1) 

a policy study; and (2) a national opinion survey, an adjunct 


212 


to the policy study suggested by the study's designers as 
necessary to meet the Congressional mandate. The study began 
in September 1975 and was completed in January 1977. 

The policy study was a structured, iterative inquiry 
involving 121 eminent individuals drawn from five broad cate- 
gories: ethicists, lawyers, medical scientists, representatives 

of the public interest, and social scientists. It was carried 
out through the medium of three Policy Evaluation Instruments 
(PEIs) mailed to and completed independently by panelists. 

After the first PEI, each subsequent PEI built upon panelists' 
responses to previous iterations. 

The national opinion survey questionnaire was based, in 
part, on material generated by the first and second PEIs. It 
was administered to a probability sample of 1,679 Americans in 
individual face-to-face interviews. In order to provide a 
basis for evaluating public understanding and attitude a paral- 
lel version of the questionnaire was included in the third PEI 
sent to consultant panelists. 

The method? used to conduct the special study are described 
in this appendix to the report. They are presented in the 
following order: study management; policy study; national 

opinion survey; and preparation of the final report. 


213 


STUDY MANAGEMENT 



This study was a fully integrated effort undertaken jointly by 
Policy Research Incorporated and the Center for Technology Assess- 
ment of the New Jersey Institute of Technology. The study was 
headquartered in the offices of Policy Research Incorporated, 
Baltimore, Maryland. 

Study Design 
and 

Management 
Group (SDMG) 

The study was designed and implemented by an eight member Study 
Design and Management Group (SDMG). This group, which represented 
a balance of expertise in the medical, legal, ethical and social 
areas: formulated the initial design; monitored its implementa- 

tion; revised the design and guided the development of the pro- 
ject to meet the objectives of the study; and reviewed all re- 
ports issued. Implementation of the study design flowed from 
the SDMG through a Project Coordinator to the other members of the 
Study Coordinating Staff, who were full-time employees of Policy 
Research Incorporated. 

Study 

Coordinating 
Staff (SCS) 

The Study Coordinating Staff (SCS) was responsible for the opera- 
tional functions of the study, including processing, reviewing, 
synthesizing, and summarizing the results of the PEIs; preparing 
drafts of the final report, and maintaining contact with members 
of the Consultant Panel. 

Consultants 
to the 
SDMG 

Five consultants were retained to aid the Study Design and Manage- 
ment Group in carrying out their activities. The Consultants to 
the SDMG functioned as independent reviewers of the various instru 


merits and reports produced by the SDMG. They were chosen for 
their diverse expertise and different viewpoints to add scope to 


214 


Consultants 
to the 
Study 


Meetings , 
Presentations, 
Communications 
with the 
Commission 


the project management, and to enhance the quality of the study 
products . 

A number of additional consultants participated in the study. 

The roles of these consultants included pretesting instruments, 
and supplying specific technical assistance to the study. 

Appendix 2 lists members of the Study Design and Management 
Group, Consultants to the SDMG, the Study Coordinating Staff, 
and other study staff members; Appendix 3 consultants to the study. 

The SDMG met fourteen times throughout the conduct of the study 
to monitor and guide its progress. The commission’s Project Moni- 
tor attended these meetings on a regular basis in order to main- 
tain communication between the project and the Commission staff 
and the Commission itself. All materials related to the study 
were forwarded to the Commission staff and members of the Com- 
mission as they were produced. In addition, four presentations 
were made to the Commission during the course of the study. 

The first presentation related to the design of the study 
and initial pi'ogress, including development of the issues for 
inclusion in the study, the selection of panelists, and the first 
Policy Evaluation Instrument. This presentation was made in 
October, 1975. (Separate meetings were held with Commission staff 
on the subject of issues selection.) Interim reports were pre- 
sented to the Commission in April, 1976, and September, 1976. 

These reports constituted interim products of the study. A 
final presentation to the Commission was made in 1977 after sub- 
mission of the final report of the study. 


215 


INTRODUCTION TO THE POLICY STUDY 

Inherent in the policies which people recommend is an impli- 
cit view of the future which is predicated on their view of 
the past and of the present. Consequently, the most fruitful 
way of understanding the ethical, legal, and social implica- 
tions of advances in biomedical and behavioral technology is 
to engage in a realistic discussion of the policy alternatives 
available to influence these advances, and the problems inherent 
in the means by which these advances are produced. The study 
approach began with the assumption that normative plans for the 
future are idealized plans for extending what is known in 
the present. The approach based the implications of advances 
and policies on the projections of as many diverse disciplines, 
professions, and types of personalities as feasible. Moreover, 
it encompassed ethical as well as technical considerations, and 
therefore followed a system of inquiry suggested by Churchman in 
the Design of Inquiring Systems (Basic Books, NY, 1971). 

The methodology elaborated to conduct this study repre- 
sents a new method of systematically analyzing complex, value- 
laden, policy-related subjects. Essentially, it is a dynamic 
communications process in which information generated by a 
group at one point in time is elaborated on in the next. This 
dynamic communications process incorporated a dialectic between 
contrasting views, designed to produce the best underlying pro 
and contra arguments which form the basis of various policy 
alternatives, resource allocation alternatives, or outcomes, 
impacts and effects. Through this process as many considerations 


216 


as possible are brought into the discussion. 

Organization The study involved the discussion of the implications of advances, 

of the 

Policy and policy alternatives available to control and regulate the 

Study 

conduct of research and the distribution of technology. This 
discussion focused on five quintessential subject areas in re- 
search and technology which currently confront the various facets 
of the health system. The persons who participated in the dis- 
cussion were 121 eminent individuals, collectively known as the 
Consultant Panel, representing different perspectives on the 
problem. 

In order to provide a variety of views and perspectives 
pertinent to the subject of the study, the Consultant Panel 
consisted of persons drawn from the following five broad cate- 
gories, with about 2.5 in each category: ethicists; lawyers; 

medical scientists; representatives of the public interest; 
and social scientists. 

The discussion was carried out through three Policy Eval- 
uation Instruments (PEIs) mailed to the Consultant Panel on 
February 6, May 12, and August 14, 1976. Each PEI subsequent 
to the first built upon panelists’ responses to previous PEIs. 
During the course of filling out these PEIs panelists were 
able to make known their views, arguments, and assumptions 
about advances in biomedical and behavioral research and tech- 
nology and about policies which might be implemented to deal 
with those advances. The discussion of advances and policies 
unfolded from the flow of information from one PEI to the next. 


The progress of the discussion was from the general to the 


217 


specific; from general implications of a number of quintes- 
sential advances, to specific implications of stated policies 
with respect to advances, to specific positions with respect 
to selected advances; and from general policies to address 
biomedical and behavioral research and the implementation of 
the resultant technology, to specific policies governing many 
aspects of research and the implementation of resultant tech- 
nology. Each PEI was designed to allow a dialectic between 
competing views. 

Individual respondents remained anonymous throughout 
the dialectic process so that points of view could be expressed 
without the obligation to adhere to past positions, or to be 
fixed in one’s positions. Moreover, since panelists could 
independently and freely assess the material presented, inter- 
personal considerations and group dynamics were minimized. 


218 


SELECTION OF THE CONSULTANT PANEL 

In order to provide a variety of views and perspectives perti- 
nent to the subject of the study, the Consultant Panel consisted 
of persons drawn from the following five broad categories: 

* ethicists, philosophers, and religious leaders; 

* lawyers and members of the judiciary; 

* medical scientists and persons in related fields — 
including medical doctors from various specialized 
areas; biochemists; biophysicists and biologists; 
experimental psychologists; pharmacologists; and 
representatives of the drug, health appliance, 
research apparatus, and hospital industries; 

* representatives of the public interest — including 
members of the Congress and other legislative bodies; 
members of the Executive Branch of the Government; and 
members of special interest groups including minority 
groups, consumer interest groups, and organizations 
who maintain a particular moral/ethical position 
vis-a-vis the practice of medicine; and 

* social scientists — including sociologists; psycho- 
logists; economists; urbanologists ; planners in 
various disciplines; and managers and administrators. 

The Consultant Panel was selected in a number of discrete waves 
to insure that a balanced panel resulted from the selection pro- 
cess. 


At the time the proposal for the study was submitted, 
approximately one-half the number of persons required to 
make up the panel had been selected and confirmed. After the 
contract was signed, work was begun on compiling lists of poten- 
tial members for the Consultant Panel and assembling biographic 
data on each candidate. Nominations were generated from project 
staff and consultants, the staff of the Commission, the chair- 
persons and ranking minority members of seven Congressional Com- 
mittees and Subcommittees relevant to the study, and from con- 


219 


finned panelists themselves. 

Biographical data on each nominated potential panelist were 
collected from various published sources. A total of 30 differ- 
ent reference works were consulted in an attempt to provide 
sufficient biographical information to reviewers. The data 
were transcribed onto Panelist Nominee Forms which were distri- 
buted to a Panel Selection Task Force for evaluation. 

The Panel Selection Task Force consisted of four persons 
drawn from the Study Design and Management Group (SDMG) and 
Study Coordinating Staff (SCS) . Each reviewer made an indepen- 
dent assessment of the appropriateness of a nominee to be a 
panelist. The major criteria for selection to the Consultant 
Panel were qualifications and experience relevant to the study. 
Final selection of panelists was made from the pool of those 
nominees felt to be appropriately qualified by the reviewers. 
Qualified persons were selected to the panel so as to ensure 
that minorities, including women, were represented and that 
panelists were drawn from all regions of the country. 

Letters of invitation to selected potential panelists were 
mailed at various times during the study. Each person approach- 
ed received a letter inviting him/her to join the Consultant 
Panel, a copy of the technical proposal, some other materials 
pertinent to the study, and a Consultant Panelist Information 
Survey. The Consultant Panelist Information Survey form was 
developed to allow accepting panelists to provide the study 
team with certain administrative data, and to allow a panelist 
to place himself or herself in the most appropriate category. 


220 


Returned Consultant Panelist Information Survey forms were re- 
viewed and the information was transferred to Panelist Control 
Cards. Analysis of returned survey forms produced the data 
necessary to balance the panel to the greatest extent possible. 
Persons selected in later waves of the selection process were 
no less qualified than those selected earlier. 

The panel selection process resulted in the nomination and 
review of 680 people. Of this number, 281 were invited to serve 
as panelists at some point in the study, and 149 people consented 
to serve (Figure 1.1). Panelists who were unable to continue 
with the study at any time were replaced from the pool of quali- 
fied persons within their own category so as to maintain an 
appropriately balanced panel. At each mailing of a Policy Eval- 
uation Instrument, the Consultant Panel consisted of at least 
125 people. The final Consultant Panel represents the 121 people 
who completed one or more Policy Evaluation Instruments. 

Appendix 4 lists the names and affiliations of members of 


the Consultant Panel. 


221 


SELECTION OF ISSUES 

An Issues Clarification Meeting (ICM) was planned in September, 
1975 and held in Baltimore on October 25 and 26, 1975. The 
purpose of this meeting was the development of: (1) a limited 

number of quintessential subject areas in which advances in 
biomedical and behavioral research and technology might be 
expected to take place; (2) the important societal concerns 
that these advances would challenge; and (3) some of the poten- 
tial problems that might be produced through the impact of 
particular subjects on specific concerns. Two panelists from 
each of the five panelist categories (ethicists, lawyers, medi- 
cal scientists, representatives of the public interest, and 
social scientists) were participants in the ICM. 

Prior to the meeting, each participant completed a pre- 
meeting assignment that formed the starting point for the meeting 
itself. This assignment included recommending subject areas 
for inclusion in the study, and indicating relevant concerns 
related to each subject area. At the opening of the meeting, 
participants were divided into two groups of five persons (one 
from each panelist category). 

Each group was provided with a copy of the subject areas 
and societal concerns identified by members of that group in the 
pre-meeting assignment. Participants added to the subject areas 
and social concerns listed. Separate votes on the importance 
of the subject areas and societal concerns identified were then 
taken. Subject areas were ranked according to socio-political 
importance, and the potential for revealing differences of opin- 


222 


ion among the five panelist categories. Additionally, the 
eight top-ranked subject areas were rated for their impact on 
the societal concerns considered most important. 

Subsequently, the two groups met in plenary session to com- 
pare and discuss the items that had been identified. A final 
vote on the socio-political importance and potential for re- 
vealing differences of opinion among panelist categories was 
taken on a combined list of subject areas produced from the 
eight most important subject areas identified by each small 
group. 

The output of the Issues Clarification Meeting was review- 
ed by the SDMG. The SDMG analyzed the ratings of the subject 
areas, and the relative importance of the societal concerns. 

In the final analysis, the subject areas that were selected re- 
presented the minimum number of subject areas that would reflect 
the maximum number of important societal concerns. Following 
several meetings with the staff of the Commission, the final 
list of subject areas was selected as foci of inquiry for the 
study. The five subject areas chosen were: Systematic Control 

of Behavior s Reproductive Engineering ; Genetic Screening ; Exten- 
sion of Life; and Data Banks > Computer Technology . 


223 


THE FIRST POLICY EVALUATION INSTRUMENT 

The first Policy Evaluation Instrument (PEI) was designed to 
identify foreseen implications of technological advances in 
biomedical and behavioral research and technology, and to sug- 
gest policies to respond to these implications. 

Design of Two members of the SDMG independently developed design skeletons 

First PEI 

Evaluation for the Evaluation Workbook section of the first PEI. One 

Workbook 

design skeleton emphasized the development of policies based 
on the implications of specified advances in biomedical and 
behavioral research and technology. The other emphasized the 
elaboration of general policies related to scenarios which were 
based on advances in biomedical and behavioral research. The 
SDMG decided to incorporate aspects of both design skeletons 
in the elaboration of the final design of the Evaluation Workbook. 

In order to obtain three advances in each subject area, 
the author of a Background Paper and at least two other recog- 
nized experts in the particular subject area were asked to sug- 
gest and describe from three to five advances in the subject 
area that were expected to occur in the next 20 years, and to 
rank them in order of importance with regard to the impact that 
the advance would have on society. Descriptions of advances 
in a subject area were reviewed by the Principal Investigator 
and other members of the study staff, and common advances iden- 
tified. The three most often mentioned advances in each sub- 
ject area were selected for inclusion in the first PEI, yielding 
a total of 15 quintessential advances for the five subject areas. 

Forty-eight scenarios were written by members of the SDMG 


224 


Pretest 


and reviewed by the SDMG and the consultants to the SDMG. The 
six scenarios receiving the most votes in a poll of the SDMG 
and consultants to the SDMG were included in the first PEI. A 
scenario pertinent to each subject area was included, and one 
scenario cut across all subject areas. 

Ten pretesters, two from each of the study's five categories 
of panelists, were asked to complete the first pretest version 
of the first PEI, and to complete the Pretesters Evaluation 
Workbook that accompanied the instrument. Pretesters were sel- 
ected to be representative of panelists insofar as possible, 
except that all resided in the Baltimore-Washington area. Two 
students of the New Jersey Institute of Technology also 
acted as pretesters of the first PEI. Nine of the twelve pre- 
testers completed the task. On the basis of these pretests 
and reviews, the subsequent discussions, and the votes of the 
SDMG and the Consultants to the SDMG with respect to what items 
were essential to the study, a second pretest version of the 
first PEI was prepared. 

Two additional consultants pretested this version of the 
first PEI and completed the Pretesters Evaluation Workbook. The 
major concerns at this juncture were: (1) the time it would 

take for a panelist to complete the PEI and; (2) the comprehen- 
sibility of items. Subsequent to the second pretest of the 
first PEI, a meeting, attended by members of the SDMG, Consul- 
tants to the SDMG, and project staff, was held to discuss pre- 
test results and further refine the first PEI. The final version 


225 


Background 

Papers 


Introductory- 

Material 


of the PEI was mailed to the Consultant Panel on February 6, 

1976; it consisted of three sections: background papers, intro- 

ductory materials, and an Evaluation Workbook. 

A background paper was written for each of the five subject 
areas. They were written by members of the Consultant Panel 
who had expressed an interest in writing such a paper and who 
had demonstrated expertise in the particular subject area. 
Background paper writers were provided with a standard outline, 
so that the papers would include a comparable degree of infor- 
mation. Papers received from authors were reviewed by members 
of the SDMG, supplemented when appropriate by members of the 
SDMG or consultants to the SDMG who were experts in a particular 
subject area, and edited by project staff. 

The introductory materials consisted of three documents: Intro- 

duction, Definitions, and Completed Example. The Completed 
Example was prepared after the contents of the Evaluation Work- 
book had been finalized. Responses given in the Completed Ex- 
ample were based on those obtained in pretests of the instru- 
ment for an advance and scenario not included in the final ver- 
sion of the PEI. Certain terms were identified for which stand- 
ard definitions were provided. The terms were defined from a 
variety of sources: dictionaries and other reference works, 

the SDMG, its consultants, and members of the Consultant Panel. 
The final version of the Introduction was written after the 
contents of the first PEI had been finalized. The purpose of 
this booklet was to acquaint panelists with the study process. 


226 


Evaluation The Evaluation Workbook was arranged by subject area. For 

Workbook 

each subject area under consideration, panelists were asked 
to review the three selected advances and to choose from the 
advances listed (or from the one they were allowed to add) the 
one advance that was most important, that is, the one having 
the most significant implications for society. For this most 
important advance, panelists were asked to identify and rank up 
to three significant types of implications of the advance, and 
to elaborate on these implications. Finally, panelists were 
asked to choose among separate policies with respect to (1) 
research that gave rise to the advance, and (2) the implementa- 
tion of the advance itself, and, if appropriate, to elaborate 
on these policies. 

The six scenarios followed the five subject areas. In 
the scenarios, panelists were provided with two options, asked 
to decide which they favored, and then asked to elaborate on 
the basis for their decision. Finally, they were asked to se- 
lect which groups and agencies should participate in the resolu- 
tion of the issue, and to describe a policy that would be help- 
ful in resolving issues of the type depicted in the scenario. 


227 


THE SECOND POLICY EVALUATION INSTRUMENT 

The second Policy Evaluation Instrument was designed to examine 
the implications of policies that might be implemented with re- 
spect to selected technological advances in biomedical and behav- 
ioral research, and to evaluate policies pertinent to the sub- 
ject of the study, taken as a whole. 

Of the 15 advances and 6 scenarios included in the first 
PEI, five were brought forward to the second PEI to serve as 
models in this respect. They were: Actions of psychopharma- 

cologlcal agents further understood ; Select-a-boy 3 Select-a- 
glrl makretable kits; Amnloc&itesls becomes routine; Environmen- 
tal causes of disease and trauma further controlled; and Comput- 
erized medical records In use. These five items were chosen be- 
cause of the importance panelists attached to them; the wide 
range of opinions held by panelists regarding research and imple- 
mentation of the advance; or to ensure that they encompassed the 
study's five subject areas. 

Pretest A draft version of the second PEI was pretested by six people, 

at least one from each of the study's five panelist categories. 

As with the first PEI, each pretester completed a draft version 
of the instrument and a Ptetester's Evaluation Workbook. The 
comments made by pretesters were reviewed and discussed by mem- 
bers of the SDMG. On the basis of these reviews, the subsequent 
discussions and the votes of the SDMG and the Consultants to 
the SDMG with respect to what items were essential to the study, 
the final version of the second PEI was prepared. The second 
Policy Evaluation Instrument was mailed to panelists on May 12, 


228 


Synthesis 

Papers 


Introductory 

Materials 


1976; it consisted of three sections: synthesis papers, intro- 

ductory materials, and an Evaluation Workbook. 

Panelists were provided with a synthesis paper for each advance 
or scenario brought forward from the first PEI. Each synthesis 
paper consisted of three parts: a pro position statement advo- 

cating the promotion of research and implementation of the ad- 
vance; a contra position statement advocating control or limi- 
tation of research and implementation of the advance; and gen- 
eral summaries of the policies and implications. Each position 
statement was written by a panelist who selected the particular 
policy for the advance in the first PEI. 

Position statement writers were provided with and drew on 
the anonymous responses of all panelists who also selected the 
same overall policy to respond to the advance. The authors of 
position statements were allowed considerable latitude in pre- 
senting the best possible argument for the policy they advocated, 
and in developing the implications of the advance. The general 
summaries of policies and implications, the results of the first 
PEI, were developed by project staff. In addition, all position 
statements were reviewed and edited by project staff. 

Introductory materials included with the second PEI consisted of 
an Introduction and a Completed Example. The Introduction con- 
tained a brief statistical summary of the results of the first 
PEI, a discussion of the development and intent of the second 
PEI, and instructions for completing the PEI. The Completed 
Example presented examples of both implications of policies 


229 


material and general policy statement material. The implica- 
tions of policies examples were drawn from material contained 
in the first PEI which had not been carried over. The general 
policy statement examples were drawn from policy statements 
which had not been selected by the SDMG for inclusion in the 
second PEI. As in the first PEI, final drafts of these documents 
were prepared after the Evaluation Workbook had been finished. 

Evaluation In the second PEI, as in the first, there were two major parts 

Workbook 

in the Evaluation Workbook — a section on implications of 
policies, and a section on general policy statements. 

The implications of policies part of the workbook built 
upon the synthesis papers, and particularly on the position 
statements advocating either promotion of research and implemen- 
tation or control of research and implementation. 

In this part of the PEI, panelists were asked to identify 
which of the two opposite policies they would least like to see 
implemented. After selecting the policy least liked, panelists 
were asked to think about the implications of this (antithetical) 
policy not only in terms of benefits or harms intrinsic to the 
technology, but also the additional harms or benefits that 
might stem from implementing the policy itself. 

Panelists were asked to identify and describe briefly the 
three most significant negative consequences (undesirable effects, 
disbenefits) that would occur if the policy they least liked 
were to be implemented. They were also asked to identify what 
group or groups, if any, would be particularly affected by these 
negative consequences. Finally, panelists were asked to describe 


230 


what specific policy could be adopted, or what other steps 
could be taken to ameliorate the most significant negative con- 
sequence of implementing the policy least liked, thereby making 
it more tolerable. Such policies could be aimed at preventing 
or minimizing the occurrence of the negative consequence or at 
compensating for it were it to occur. 

The general policy statements part of the workbook con- 
tained 23 major policy statements and their associated sets of 
subsidiary statements. A list of general policy statements was 
compiled from the results of the first PEI; a review of the 
legislative intent in setting up the Commission, the mandate for 
the study; and from various documents produced by the Commission 
itself. The initial list of policy statements was submitted to 
the SDMG for review and the final list of items was selected on 
the basis of the recommendation of the SDMG. 

In the general policy statements part of the Evaluation 
Workbook, panelists were asked to vote on a number of policies 
relevant to the study. Each policy was presented in the form 
of a statement and panelists were asked to decide whether or 
not they agreed with the statement and whether or not it was 
urgent to implement the policy. Other general policies that 
panelists considered should be implemented urgently could be 
added in space provided for that purpose. Panelists were then 
asked to choose the five most urgent policies, and to rank them 
in order of urgency. Finally, they were asked to elaborate on 


the three policies selected as most urgent to implement. 


231 


THE THIRD POLICY EVALUATION INSTRUMENT 

The purpose of the third and final PEI was to examine the con- 
sequences of a possible national policy that might be adopted 
with respect to biomedical and behavioral research and the im- 
plementation of the technologies that result from such research. 
The material brought forward from the second PEI consisted of 
the results of the responses to the general policy statements 
and the panelists’ own descriptions of the most urgent policies. 

Pretest Five persons completed copies of a draft version of the third 

PEI and a Pre tester's Evaluation Workbook which accompanied the 
instrument. As in earlier iterations of the study, reviewers' 
comments were reviewed and discussed by members of the SDMG. 

The final version of the third PEI was based on these discus- 
sions and on the votes of the SDMG and the Consultants to the 
SDMG with respect to what items were essential to the study. 

This version of the third PEI was mailed to the panel on 
August 14, 1976; it consisted of three sections: a synthesis 

paper, introductory materials, and an Evaluation Workbook. 

Synthesis The synthesis paper contained an overview of responses to the 

Paper 

general policy statements from the second PEI, and a general 
summary of panelists' responses to each separate policy state- 
ment, prepared by project staff. The overview identified, 
interpreted, and summarized the salient dimensions underlying 
panelists' responses to the general policy statements. Each 
general summary of a policy statement followed a common outline, 
reporting as faithfully as possible panelists' elaborations of 


232 


the policy. 

In order to insure that the general summaries prepared by 
the project staff accurately reported what panelists had said, 
the general summaries and verbatim transcripts of panelists’ re- 
sponses were sent to two members of the Consultant Panel for 
review. The two panelists, each reviewing one-half of the 
general summaries, were asked to examine each general summary 
in conjunction with the verbatim transcripts to identify and 
correct any significant biases or deficiencies in the summary. 
Reviewers’ comments were taken into account in preparing the 
final synthesis paper. 

Reviewers were also asked to identify, interpret, and 
summarize the salient dimensions underlying panelists' responses 
for those general policy statements reviewed, and to provide an 
overview as a summary of their findings. The separate over- 
views were combined and edited by the project staff. This 
composite review was sent to each reviewer for comment to insure 
that it met the intent of the original review. 

Finally, these two panelists were asked to review four 
policy scenarios which were developed by the SDMG on the basis 
of the results of the general policy statements part of the 
second PEI to serve as the principal focus of the third PEI. 

The purpose of this review was to ensure that the policy scen- 
arios reflected the content of panelists' elaborations to the 
general policy statements. 


233 


Introductory 

Materials 


Evaluation 

Workbook 


The introductory materials for the third PEI included an Intro- 
duction and a Completed Example. The Introduction contained a 
summary of the statistical results from the second PEI, some 
background on the intent of the instrument, and instructions for 
completing the instrument. The Completed Example used material 
on health care delivery as the basis for policy questions and 
resource allocation decisions. Examples of general opinion 
questions were drawn from questions deleted from earlier ver- 
sions of the national opinion survey. 

The focus of the third PEI was on general policies with respect 
to research and implementation rather than on specific research 
projects or the implementation of specific technologies. It was 
not judged possible to identify all the advances that might re- 
sult from biomedical and behavioral research and technology; con- 
sequently, aggregate panel and advisor comments clearly indi- 
cated that the most meaningful purpose would be to identify and 
discuss mechanisms to continually evaluate, regulate, control, 
and direct research and implementation. In this way it would be 
feasible to examine the likely impact of the policies on society, 
and on the research and implementation process itself. 

The third and final PEI drew together the policies pre- 
viously described by panelists to deal with biomedical and be- 
havioral research advances, the resultant technologies, and 
the implications of implementing the policies themselves. 

In the third PEI panelists were asked: 


234 


* to examine four policy scenarios that collectively 
described a possible national policy with respect to 
biomedical and behavioral research and technology, 
each scenario dealing with one aspect of the national 
policy. The four policy scenarios were: 

— Permanent National Commission; 

Public involvement in policy decision-making ; 

— Biomedical and behavioral research; and 

Implementation of biomedical and behavioral 
technologies . 

* to review past trends in expenditures for health 
related research, and to establish priorities. 

* to respond to a number of general opinion questions. 

* to describe what they thought might occur if the 
national policy described in the four scenarios was 
implemented, and what might occur if the policy was 
not implemented. 

For each policy scenario panelists were asked to consider 
the implications of the national policy the scenario described. 
First they were asked to identify and describe up to two posi- 
tive consequences (desirable effects, benefits) and up to two 
negative consequences (undesirable effects, disbenefits) antic- 
ipated if the policy described in the scenario were implemented. 
Next, panelists were asked to identify and describe up to two 
barriers to implementing the policy described in the scenario, 
and the ways in which these barriers might be overcome. Final- 
ly, panelists were asked to indicate the degree to which they 
supported or opposed the particular policies that comprised the 
national policy described in the scenario, and to offer any 
specific amendments. 

In the resource allocation part of the Evaluation Workbook 
panelists were provided with a brief overview of national re- 


235 


sources devoted to health and health research. They were asked 
to indicate their preferred allocations for health and health 
research vis-a-vis other activities, and the relative priori- 
ties that should be afforded to the different types of health 
research activities described. 

In the general opinion questions part of the Evaluation 
Workbook, panelists were asked to respond to the same series of 
questions that were asked of the general public in the national 
opinion survey adjunct to the policy study. 

Finally, panelists were asked to write two brief newspaper 
stories that might be filed by a science reporter in 1999: 

(1) if existing policies with respect to biomedical and behav- 
ioral research and technology continued to operate unchanged 
until that time; and (2) if the policies described in the third 
PEI's four policy scenarios were implemented in the late 1970s. 


236 


ANALYSIS AND SUMMARIZATION OF PEI DATA 

At each mailing of a Policy Evaluation Instrument, the Consul 
tant Panel consisted of at least 125 people. The response rates 
for the three PEIs were 76%, 86%, and 88%, respectively (Figure 
1.2). A total of 121 panelists completed at least one Policy 
Evaluation Instrument and 87 panelists (72% of those completing 
PEIs) completed all three instruments; 20% completed two PEIs. 
Each PEI took approximately six to eight hours to complete. The 
intake period for each PEI was 40 days from the date following 
mailing. 

Each step of the analysis process was carried out system- 
atically and every effort made to insure panelists’ views were 
reported accurately. Each Policy Evaluation Instrument con- 
tained both structured and open-ended questions; the analytic 
techniques applied to each PEI were the same. Structured ques- 
tions were analyzed statistically, and responses among self- 
assigned categories of panelists were compared. 

For open-ended questions, all verbatim responses were 
transcribed and then stored, sorted, and retrieved by computer. 
A summary of responses to each PEI item was prepared by project 
staff from the resultant printouts. Each summary represented, 
as completely as possible, the ideas expressed by panelists who 
responded to an item. Where appropriate, overviews of the re- 
sponses were also prepared. 

Each of the staff summaries were then submitted for criti- 
cal review to a consultant panelist. The objectives of this re 
view were to: (1) evaluate the summaries for accuracy in 


237 


reporting panelists' responses (and to correct any biases 
or deficiencies identified), and (2) identify, interpret, and 
summarize the salient dimensions in panelists' responses. In 
order to accomplish these objectives, panelist reviewers were 
provided with printouts of the verbatim responses, as well as 
with the staff summaries and overviews, and a set of instruc- 
tions . 

Another panelist was asked to review independently staff 
summaries pertaining to an entire part of a PEI. The objective 
of this review was to identify, interpret, and summarize the 
salient dimensions common to all the items summarized, those 
that cut across several, and those unique to a particular item. 
The findings of these independent reviews were then compared and 
synthesized; they formed the basis for drafting the study report. 


238 


INTRODUCTION TO THE NATIONAL OPINION SURVEY 

In order to address that item of the study mandate which called 
for "an analysis and evaluation of public understanding" of the 
implications of advances in biomedical and behavioral research, 
the SDMG recoiamended that a national survey of public opinion be 
conducted as part of the special study. The Commission approved 
of this adjunct to the special study in April; the necessary amend- 
ment to the contract was subsequently signed, and work begun in 
May 1976. 

The national opinion survey was closely integrated with 
the policy study. The items for the survey questionnaire were 
drawn from, or based on, those contained in the first two PEIs. 

In order to provide a basis for evaluating public understanding 
and attitude a parallel version of the national opinion survey 
questionnaire was included in the third PEI as a set of general 
opinion questions. 

The administration of the survey questionnaire and subse- 
quent data tabulations was subcontracted to Louis Harris and 
Associates Inc.., the result of a competitive procurement. Re- 
sponsibility for development of the survey instrument, specifi- 
cation of the analytic framework, and evaluation of the results 
remained with the SDMGo 

In addition to the survey, a comprehensive review of the 
literature on public attitudes toward research and technology, 
particularly biomedical and behavioral research and technology, 
was also undertaken to broaden the perspective of the inquiry. 


239 


DESIGN OF THE SURVEY QUESTIONNAIRE 

The national opinion survey was designed to elicit public 
sentiment towards advances in biomedical and behavioral research 
and technology, and opinions about appropriate policies to deal 
with them. The questionnaire itself was designed to be admini- 
stered by an interviewer in a face-to-face interview of less 
than one hour. 

Questionnaire Starting in late May, an intital draft of the questionnaire was 

Development 

and Pretest developed by the SDMG based upon material from the first and 

second PEIs. The initial draft was completed on June 11, 1976, 
and forwarded to the SDMG, Consultants to the SDMG, and Project 
Monitor for review. Additional copies of this draft were pro- 
vided to the Project Monitor for review by the Commission and 
for initiating Office of Management and Budget clearance proce- 
dures. The initial draft was revised on the basis of reviewer 
comments, reviewed again, and revised again for the first pre- 
test version. 

The pretests were conducted by Hollander, Cohen Associates, 
Inc., an opinion research organization located in Baltimore. 

The first pretest consisted of ten interviews; persons were 
selected to provide responses from men and women of a variety 
of ages, but not a wide geographic dispersion. Two interviewers, 
one of them black, conducted this pretest. The pretest version 
was also reviewed by the SDMG, selected Consultants to the SDMG, 
Louis Harris and Associates, and the Project Monitor and other 
Commission staff. Review and evaluation of the first pretest 
draft, and the results of the pretest itself led to the develop- 


240 


ment of the second pretest version. 

The second pretest consisted of three series of ten inter- 
views. These interviews were obtained from men and women of 
different ages, and sufficiently dispersed through the Balti- 
more metropolitan area to provide some representation by race 
and socio-economic status. Three interviewers, one of them 
black, were used for this series of pretests. The second pre- 
test version was reviewed by the same individuals who reviewed 
the first, and, as in the case of the first pretest, a debrief- 
ing meeting was held with the interviewers following the pre- 
test . 

A draft of the proposed final instrument was prepared fol- 
lowing the second pretest, reviewed by the groups noted above, 
and forwarded to the Commission for its review. The final in- 
strument resulted from this review. The instrument was final- 
ized on August 9, 1976; Office of Management and Budget clear- 
ance was received on September 10, 1976. Following reproduction 
of the instrument, administration began in late September 1976, 
and was completed in early November 1976. 


241 


ADMINISTRATION OF THE QUESTIONNAIRE AND TABULATION OF RESULTS 

Sample The national opinion survey questionnaire was administered 

Selection 

to a stratified national sample of the noninstitutionalized 
civilian population of the 48 continental United States. The 
sample was based on the latest census information available 
for the population of each state in the country, as well as on 
the population living in standard metropolitan areas and in 
the rest of the country. These figures were updated by 
intercensal estimates produced annually by the Bureau of the 
Census, and sample locations revised biennially to reflect 
changes in the country's demographic profile. 

A random sample of the population was drawn using multi- 
stage cluster sampling, a method which assures every household 
a statistically equal chance of being drawn into a given sur- 
vey. The national sample was first stratified in two dimen- 
sions: by geographic region (east, midwest, south, and west), 

and by size of place within each region (city, suburb, town, 
and rural area). This stratification insured that the ultimate 
selection of interviews reflected within one percentage point 
the actual proportions of U.S. residents living in different 
regions and community types. 

Within each stratum the selection of the ultimate sampling 
unit (a cluster of adjacent households) was achieved by a series 
of steps. The cities, suburbs, towns, and rural areas were 
listed according to population size from biggest to smallest 
within a region and then a precise location was selected by a 
random pattern which guarantees a probability proportional to 


242 


census estimates of the given location’s respective household 
populations. The next step was to construct a detailed map 
of the selected locations, which contain approximately 30 
households each. This process was carried out in the New York 
offices of Louis Harris and Associates. 

Using the randomly selected starting point, and the rout- 
ing pattern provided, interviewers contacted 19 households in 
each cluster. At each household the interviewer listed by 
age and sex, all adults who lived in that household. Then, 
using a predetermined procedure to ensure that the proper 
number of respondents of each sex and age were sampled, the 
interviewer selected which member of that household was to be 
interviewed. If the person was not at home or not available, 
the interviewer made an appointment to conduct the interview. 

If no one was at home at the initial call, the interviewer 
made three callbacks, on different days and at different times 
of the day. If, after the initial contact and three call-backs, 

no one was at home, the potential respondent was dropped and 
not replaced. 

When a sampled person refused to be interviewed, the inter- 
viewer contacted the next household in the pattern and substi- 
tued the appropriate adult at that household for the sampled 
person who refused to be interviewed. 

Following the procedures outlined above 2,503 households 
were contacted and 1,679 interviews were conducted, achieving 
a completion rate of 67%. In 19% of the households contacted, 
the respondent refused to be interviewed; in 14% of the sampled 


243 


Informed 
Consent , 

Conf identiality 
of Responses 


Validation 


households no interview was completed because no one was home 
on the intital contact or on the three subsequent callbacks. 

The response rate falls within the usual range of response rates 
for this type of survey. 

Prior to commencing the interview potential respondents were 
read a statement of purpose that described: the purpose of the 

study; the content of the questionnaire; the processing, analy- 
sis and presentation of responses to insure that the confiden- 
tiality of responses would be maintained; a respondent’s right 
to refuse to answer any question; and the anticipated average 
length of an interview. 

Respondents who consented to be interviewed were given a 
copy of this statement to keep, and a postage paid card to mail 
to Policy Research Incorporated, if they wanted to receive the 
results of the survey. Twenty-four percent of the respondents 
requested the results of the survey. 

No individual respondent will ever be identified. Face 
(control) sheets were removed and destroyed as soon as process- 
ing was completed. No identifying information appears on the 
data tape. All responses are reported in aggregate form to 
protect the anonymity of respondents. 

Before the completed questionnaires were processed, they were 
turned over to an independent validating service within Louis 
Harris and Associates. This service rechecked approximately 
20% of each interviewer's respondents to guarantee that the work 
was properly conducted and completed according to all specified 


procedures . 


244 


Data Once validation was completed and editing checks were made, open- 

Processing 

ended (unstructured) questions were coded to permit computer pro- 
cessing. Coding schemes were developed by two members of the 
SDMG who read approximately one fifth of the questionnaires and 
all of the completed PEI general opinion questions prior to final- 
izing the coding schemes. The coding schemes permitted respon- 
dents’ actual statements to be recorded as completely as possi- 
ble. Following a review of the frequencies of each code, responses 
were also aggregated into sets and supersets, as appropriate, 
for purposes of analysis. 

The coded questionnaire was key punched, 100% key verified, 
and put onto magnetic tape. The data were computer edited to 
eliminate such errors as multiple-punches to closed-ended ques- 
tions and inaccuracies in skip instructions. 

Analysis An analytic framework for the questionnaire was developed by mem- 

bers of the SDMG and reviewed by the entire SDMG, consultants to 
the SDMG, Commission staff, and staff of Louis Harris and Asso- 
ciates. In designing the analytic framework emphasis was given 
to answering those questions directly related to the study man- 
date as quickly as possible. For this reason the analysis was 
limited to cross-tabulations. The final analysis specifications 
were given to Louis Harris and Associates who were responsible 
for producing frequency distribution, cross-tabulations and other 
specified analysis. 

The coding schemes and analytic framework used for the ques- 
tionnaire were also applied to the PET general opinion questions 
to ensure comparability of results. The data produced by these 
analysis were used in writing the final report. 


245 


REVIEW OF THE LITERATURE 

Because the number of questions that could be included in the 
opinion survey questionnaire was limited, a review of the liter- 
ature was carried out in order to broaden the perspective of 
the inquiry. A comprehensive review of the literature on public 
attitudes toward research and technology, particularly biomedi- 
cal and behavioral research and technology, was undertaken. In 
addition, knowledgeable individuals were contacted in an effort 
to make the review of the literature as exhaustive as possible, 
and to identify any unpublished data. 

Three computerized bibliographic searches of the literature 
were conducted. In addition, a number of institutions and indi- 
viduals were identified as potential information sources. Let- 
ters soliciting information were mailed to 244 individuals and 
organizations in the United States and overseas. Responses 
were received from approximately one-third. 

No surveys of public opinion regarding the subject of this 
study were found. However, three surveys of the general public 
on related topics were identified, as were a number of surveys 
of specific populations (e.g. physicians) on specific issues 
(e.g. abortion). A few articles about public participation in 
policy decision-making related to scientific or technological 
matters (including the biomedical and behavioral areas) were 
also revealed by the literature search. In general, the majority 
of articles identified dealt with "ethical issues" in biomedi- 
cal and behavioral research and technology or their effects on 
society, individual freedom of choice, and other concerns -- 


246 


even though the search was focused on public understanding of 
and attitude toward the subject. Such articles were written 
from an individual or small group perspective. 

In summary, there was a dearth of primary data pertinent 
to the subject of inquiry, and a large amount of opinion and 
speculation, much of it philosophical in nature. 


S 


247 


PREPARATION OF THE FINAL REPORT 

Findings from the three PEIs that comprised the policy study 
and the national opinion survey were combined in the final 
report of the study. 

The first draft of the final report was reviewed by mem- 
bers of the SDMG, consultants to the SDMG, and Commission staff. 
Based on the findings presented in the report, each reviewer 
identified what he/she considered to be the principal study con- 
clusions. In addition, in order to ensure that study findings 
were reported accurately, the Principal Investigator and another 
member of the SDMG independently compared reported findings to 
those identified by panelist reviewers and contained in the 
national opinion survey tabulations. Based on their findings 
and reviewers’ comments a second draft of the report was pre- 
pared. The second draft of the final report contained the con- 
clusions identified by reviewers after reading the findings 
reported in the first draft. 

The second draft of the report was subsequently submitted 
for review to the same groups who reviewed the first draft. 

In addition, the Principal Investigator and another member of 
the SDMG independently compared the conclusions to the findings 
to ensure their supportability . Based on their findings and 
reviewers' comments a final draft of the report was prepared. 

The final draft report was subsequently edited for publication. 


248 


Figure 1.1 

SELECTION OF THE CONSULTANT PANEL : PERSONS NOMINATED, INVITED, ACCEPTING, 

AND COMPLETING PEIs; BY CATEGORY OF PANELIST 


Selection Step 


Nominated to Consultant Panel 

83 

96 

204 

131 

166 

680 

Invited to join Consultant Panel 

35 

68 

61 

61 

56 

281 

Accepting invitation 

28 

34 

29 

26 

32 

149 

Completing at least one PEI 

25 

23 

26 

22 

25 

121 



(1) Self-assigned categorizations for accepting panelists; a priori 
categorization for all others. 

(2) Includes relevant organizations. 


Figure 1.2 

PANELISTS COMPLETING PEIs, BY CATEGORY 



First Policy Evaluation Instrument 


Number of panelists at time of PEI mailing 

26 

23 

26 

26 

28 

129 

Number completing PEI 

22 

14 

21 

21 

20 

98 

Percent completing PEI 

85% 

61% 

81% 

81% 

71% 

76% 

Second Policy Evaluation Instrument 







Number of panelists at time of PEI mailing 

25 

25 

27 

25 

26 

128 

Number completing PEI 

25 

19 

25 

20 

21 

110 

Percent completing PEI 

100% 

76% 

93% 

80% 

81% 

86% 

Third Policy Evaluation Instrument 







Number of panelists at time of PEI mailing 

25 

25 

26 

23 

26 

125 

Number completing PEI 

25 

20 

24 

21 

20 

110 

Percent completing PEI 

100% 

80% 

92% 

91% 

77% 

88% 


(1) Self-assigned categorization 


Appendix 2: 

Members of the Study Design and 
Management Group, Consultants to the 
SDMG, Study Coordinating Staff, and 
Study Administrative Staff. 




251 


MEMBERS OF THE STUDY DESIGN AND MANAGEMENT GROUP, CONSULTANTS TO THE SDMG, STUDY 
COORDINATING STAFF, AND STUDY ADMINISTRATIVE STAFF 


Study Design and Management Group (SDMG) 

Peter G. Goldschmidt 
Principal Investigator 
Policy Research Incorporated 

Irene Anne Jillson 

Assistant Principal Investigator 

Policy Research Incorporated 

Sanford Bordraan 

Assistant Principal Investigator 
Center for Technology Assessment, NJIT 

Murray Turoff 

Assistant Principal Investigator 
Center for Technology Assessment, NJIT 


Consultants to SDMG 

Norman Dalkey 
Professor 

University of California at Los Angeles 
Department of Engineering 
Los Angeles, CA 90024 
Consultant 

the RAND Corporation 
Santa Monica, CA 90406 

William Hauswirth 
Assistant Professor 
Department of Microbiology and 
Immunology 

University of Florida 
Hills-Miller Medical Center 
Gainesville, Florida 32601 

Harold Linstone 
Professor of Systems Science 
Portland State University 
Portland, Oregon 92703 


William Duerk 
Attorney-at-law 
Perito, Duerk, and Carlson 
Washington, D.C. 20036 

Prakash Grover 
Senior Epidemiologist 
Fox Chase Cancer Center 

Assistant Clinical Professor of Medicine 
University of Pennsylvania Medical School 
Philadelphia, Pennsylvania 19111 

Ian Mitroff 
Professor 

Department of Information Science 
University of Pittsburgh 
Pittsburgh, Pennsylvania 15260 

John Williamson 
Professor 

The Johns Hopkins University 
School of Hygiene and Public Health 
Baltimore, Maryland 21205 


Samuel Scheele 
President 

Social Engineering Technology, Incorporated 
Professor 

University of California at Los Angeles 
Department of Behavioral Sciences 
Los Angeles, California 90032 

Stuart Silverman 
Clinical Associate in Medicine 
Boston University Medical Center 
Boston, Massachusetts 02215 


252 


Study Coordinating Staff, Poli cy Research Incorporated 


Bruce Sanders 
Project Coordinator 

Wendie Pigiet 
Research Assistant 

Ken Dane 

Senior Research Associate 

Judith Applefeld 
Research Assistant 

Miriam Heath 
Computer Consultant 

Judith Lerner 
Research Assistant 

Faye Malitz 
Computer Consultant 

Roger Muller 
Research Associate 


Study Administrative Staff, Policy Research Incorporated 


Beverly Randall 
Administrative Assistant 

Kathleen Crouch 
Executive Secretary 

Cora Locks 

Administrative Assistant 



Contract Administrative Staff, Center for Technology Assessment, NJ IT 


William Savin 
Contract Administrator 

National Opinion Survey Personnel 


Thomas Moriarty 

Louis Harris and Associates, Inc. 
New York, New York 10036 

Sidney Hollander 

Robert Bower 
Director 

Bureau of Social Science Research 
Washington, D.C. 20036 

Hollander, Cohen Associates, Inc. 
Baltimore, Maryland 21218 

Marilee Considine 

Hollander, Cohen Associates, Inc. 

Baltimore, Maryland 21218 

Theodore Zaner 
Associate Chairman 
Department of Organizational and 
Social Sciences 

New Jersey Institute of Technology 
Newark, New Jersey 07102 

Staff of the National Commission 

Michael Yessley 
Staff Director 

Steven Thornton 
Contract Officer 

Miriam Kelty 
Project Monitor 

Bradford Gray 
Staff Member 


Appendix 3: 

Consultants to the Study 


♦ 


255 


OTHER CONSULTANTS TO THE STUDY 

Michael H. Bowler, MS 
Education Writer 
The Sunpapers 

Baltimore, Maryland 21206 

Alphonse Chapanis, PhD 
Professor of Psychology 
Chairman, Review Board on the 
Use of Human Subjects 
The Johns Hopkins University 
Baltimore, Maryland 21218 

Gary A. Chase, PhD 

Assistant Professor of Medicine 

and Biostatistics 

The Johns Hopkins University 

Baltimore, Maryland 21205 

Rodney Coe, MD 

Department of Community Medicine 
St. Louis School of Medicine 
St. Louis, Missouri 63104 

Elizabeth Crowley 
Executive Director 
Mental Health Association of 
Prince Georges County 
Riverdale, Maryland 20840 

Joao deFigueiredo , MD, ScD 
Department of Mental Hygiene 
School of Hygiene and Public 
Health 

The Johns Hopkins University 
Baltimore, Maryland 21205 

Lawrence Donner, PhD 

Associate Professor 

Institute of Psychiatry and Human 

Behavior 

School of Medicine 
University of Maryland 
Baltimore, Maryland 21201 


Eugene M. Feinblatt 
Gordon, Feinblatt, Rothman, 
Hoffberger, and Hollander 
Baltimore, Maryland 21202 

Michael Gardner, PhD 
Department of Philosophy 
University of Maryland 
College Park, Maryland 20742 

E.S.A. Hafez, MD 

Department of Gynecology and 

Obstetrics 

Wayne State University Medical 
School 

Detroit, Michigan 48201 

Neii Holtzman, MD 

Associate Professor of Pediatrics 

School of Medicine 

The Johns Hopkins University 

Baltimore, Maryland 21205 

Arno G. Motulsky, MD 
Professor of Medicine 
Division of Medical Genetics 
University of Washington 
Seattle, Washington 98195 

Walter Orlinsky 
President 

Baltimore City Council 
Baltimore, Maryland 21202 

Charlton Reed Price 
3135 Highland Place, NW 
Washington, DC 20008 

Barry Rosen 

Gordon, Feinblatt, Rothman, 
Hoffberger, and Hollander 
Baltimore, Maryland 21202 


256 


Mary V. Ruth, PhD 
Associate Professor 
Graduate Program in 
Community Health Nursing 
School of Nursing 
University of Maryland 
Baltimore, Maryland 21201 

Joseph D. Schulman, MD 
Chief 

Section on Human, Biochemical 
and Developmental Genetics 
National Institute of Child 
Health and Human Development 
National Institutes of Health 
Bethesda, Maryland 20014 


Landrum B. Shettles, MD 
Gifford Memorial Hospital, Inc. 
Randolph, Vermont 05060 

Lawrence Stern, PhD 
Assistant Professor 
Department of Philosophy 
University of Maryland 21201 

Gio Wiederhold, PhD 

Staff Consultant 

Dept, of Family, Community, and 

Preventive Medicine 

Division of Health Information 

Services 

Stanford Medical Center 
Stanford, California 94305 


257 


Appendix 4: 

Members of the Consultant Panel 



259 


MEMBERS OF THE CONSULTANT PANEL 

PERSONS WHO COMPLETED ONE OR MORE POLICY EVALUATION INSTRUMENTS 


JACOB B AGUS PHD 
RABBI, BETH EL CONGREGATION 
PROFESSOR 0? HODERN JEWISH PHILOSOPHY 
DROPSIE UNIVERSITY 
BALTIMORE MARYLAND 

GEORGE J ANNAS JD a?a 

DIRECTOR, CENTER POR LAW AND H2ALTd SCIENCES 
BOSTON UNIVERSITY SCHOOLS OF LAW AND MEDICINE 
BOSTON MASSACHUSETTS 

* H VASKEN A POS HI AN PHD 
PROPESSOR AND HEAD 

DEPARTMENT OP CELL AND DEVELOPMENTAL BIOLOGY 
PROPESSOR 0? PHARMACOLOGY 
UNIVERSITY 0? ARIZONA 
TUCSON ARIZONA 

H DAVID BANTA MD MPH 
PROFESSIONAL STAFP MEMBER 

OFFICE OP TECHNOLOGY ASSESSMENT, US CONGRESS 
ASSOCIATE CLINICAL PROFESSOR 
MOUNT SINAI SCHOOL OP MEDICINE OP CUNY 
WASHINGTON DC 

JUDITH M BARpWICK PHD 
ASSOCIATE PROFESSOR 
DEPARTMENT 0? PSYCHOLOGY 
UNIVERSITY 0? MICHIGAN 
ANN ARBOR MICHIGAN 

ROBERT J BAUM PHD 

MAN..GER, ETHICAL AND HUMAN VALUE IMPLICATIONS 
OF SCIENCE AND TECHNOLOGY PROGRAM 
NATIONAL SCIENCE FOUNDATION 
WASHINGTON DC 

A DOUGLAS BENDER PHD 

VICE PRESIDENT, PLANNING AND OPERATIONS, 
RESEARCH AND DEVELOPMENT 
SMITH KLINE AND FRENCH LABORATORIES 
PHILADELPHIA PENNSYLVANIA 

HARVEY A BENDER PHD 
EXECUTIVE DIRECTOR 

NATIONAL CENTER FOR LAW AND THE HANDICAPPED 
FROFESSOR OF BIOLOGY AND ADJUNCT PROFESSOR OF 
LAW 

UNIVERSITY OF NOTRE DAME 
SOOTH BEND INDIANA 

RUTH Y BERINI 
EXECUTIVE DIRECTOR 

NATIONAL GENETICS FOUNDATION INCORPORATED 
NEW YORK NEW YORK 

♦RICHARD H BLUM PHD 
SENIOR SCHOLAR 
STANFORD LAW SCHOOL 
STANFORD UNIVERSITY 
STANFORD CALIFORNIA 


JAMES E BOWMAN, JR MJ 
PROFESSOR 

DEPARTMENTS OF PATHOLOGY , MEDICINE, COMMITTEE 
ON GENETICS AND BIOLOGICAL SCIENCES, 
COLLEGIATE DIVISION 
DIRECTOR 

COMPREHENSIVE SICKLE CELL CENTER 
THE UNIVERSITY OF CHICAGO 
CHICAGO ILLINOIS 

♦JERALD C BRAUER PHD 

THE NAOMI SHENSTONE DONNELLEY PROFESSOR OP 
CHRISTIANITY IN THE DIVINITY SCHOOL 
THE UNIVERSITY OF CHICAGO 
CHICAGO ILLINOIS 

ROBERT A BURT JD 
PROFESSOR OF LAW AND 

PROPESSOR OF LAW IN PSYCHIATRY 
UNIVERSITY OF MICHIGAN LAW SCHOOL 
ANN ARBOR MICHIGAN 

MARTIN J BUSS PHD 
ASSOCIATE PROFESSOR 
DEPARTMENT OF RELIGION 
EMORY UNIVERSITY 
ATLANTA GEORGIA 

ALEXANDER MORGAN CAPRON LL3 
ASSOCIATE PROFESSOR OF LAW 
UNIVERSITY OF PENNSYLVANIA LAW SCHOOL 
PHILADELPHIA PENNSYLVANIA 

JAMES CARMODY PHD 

POLICY MONITOR, EXECUTIVE SECRETARIAT, PUBLIC 
HEALTH SERVICE, UNITED STATES DEPARTMENT 
OF HEALTH, EDUCATION AND WELFARE 
ROCKVILLE MARYLAND 

♦DANIEL H CARSON PHD 
5 EC RET ARY -TREASURER 
CARSON CONSULTANTS INCORPORATED 
MILWAUKEE WISCONSIN 

DAVID REYNOLDS CHALLONSS MD 
DEAN, ST LOUIS UNIVERSITY 
SCHOOL OF MEDICINE 
ST LOUIS MISSOURI 

JAMES FRANKLIN CHILDRESS PHD 

JOSEPH P KENNEDY, SR. PROFESSOR 0? CHRISTIAN 
ETHICS 

KENNEDY INSTITUTE FOR THE STUDY OF 
HUMAN REPRODUCTION AND BIOETHICS 
GEORGETOWN UNIVERSITY 
WASHINGTON DC 

♦HAROLD A COHEN PHD 
EXECUTIVE DIRECTOR 

MARYLAND HEALTH SERVICES COST REVIEW COMMISSION 
BALTIMORE MARYLAND 

SHEILA D COLLINS MA 
DIRECTOR OF PUBLICATIONS 
JOINT STRATEGY AND ACTION COMMITTEE 
NEW YORK NEW YORK 


♦ INDICATES PANELISTS WHO COMPLETED ADDITIONAL ASSIGNMENTS 


260 


ANDREW W DAHL SCD 
DIRECTOR OF PLANNING 
SAINT JOHN HOSPITAL 
DETROIT MICHIGAN 

EDWARD DAVENS HD 

COORDINATOR, MARYLAND REGIONAL MEDICAL PROGRAM 
THE JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE 
BALTIMORE MARYLAND 

LOIS DEBAKEY PHD 

PROFESSOR OF SCIENTIFIC COMMUNICATIONS 
BAYLOR COLLEGE OF MEDICINE 
HOUSTON TEXAS 

JOHN C DEFRIES PHD 

PROFESSOR OF BEHAVIORAL GENETICS 

INSTITUTE FOR BEHAVIORAL GENETICS 

UNIVERSITY OF COLORADO 

BOULDER COLORADO 

JOSE M R DELGADO MD DSC 
PROFESSOR AND CHAIRMAN 
DEPARTMENT OF PHYSIOLOGY 
AUTONOMOUS UNIVERSITY 
MADRID SPAIN 

RICHARD DELGADO 
PROFESSOR OF LAW 
UNIVERSITY OF WASHINGTON 
SEATTLE WASHINGTON 

ROBERT F DRINAN LL3 LLM T HD 
CONGRESSMAN 

US HOUSE OF REPRESENTATIVES 
WASHINGTON DC 

RCGER DWORKIN JD 
PROFESSOR OF LAW 
SCHOOL OF LAW 
INDIANA UNIVERSITY 
BLOOMINGTON INDIANA 

MERVYN M DYMALLY MA 

LIEUTENANT GOVERNOR OP CALIFORNIA 
SACRAMENTO CALIFORNIA 

♦HAROLD EDGAR 
PROFESSOR OF LAW 
SCHOOL OF I.AW 
COLUMBIA UNIVERSITY 
NSW YORK NEW YORK 

ANKE A EHRHARDT PHD 
ASSOCIATE PROFESSOR OF PSYCHOLOGY 
DEPARTMENT OF PSYCHIATRY 
STATE UNIVERSITY Or NEW YORK 
BUFFALO NEW YORK 

♦ JACK E El NS ON PHD 
PROFESSOR 

DIVISION OF SOCIOMEDICAL SCIENCES 
SCHOOL OF PUBLIC HEALTH 
COLUMBIA UNIVERSITY 
NEW YORK NEW YORK 

JOHN C FLETCHER 
PRESIDENT 

INTERFAITH METROPOLITAN THEOLOGICAL EDUCATION 
WASHINGTON DC 


JOSEPH FLETCHER 
VISITING PROFESSOR 

UNIVERSITY OF VIRGINIA MEDICAL SCHOOL 
UNIVERSITY OP TEXAS GRADUATE SCHOOL 
OF BIOMEDICAL SCIENCES 
HOUSTON TEXAS 

♦ROBERT T FRASCOUER PHD 
PROFESSOR OF ALLIED HEALTH SCIENCES 
AND HUMAN SEXUALITY 
FAIRLEIGH DICKINSON UNIVERSITY 
MADISON NEW JERSEY 

♦CHARLES PRIED JD 
PROFESSOR OF LAW 
HARVARD LAW SCHOOL 
CAMBRIDGE MASSACHUSETTS 

PAUL R FRIEDMAN 
DIRECTOR 

MENTAL HEALTH LAW PROJECT 
WASHINGTON DC 

B JAMES GEORGE, JR JD 
PROFESSOR OF LAW AND DIRECTOR 
CENTER FOR THE ADMINISTRATION 0? JUSTICE 
WAYNE ST, AT E UNIVERSITY LAW SCHOOL 
DETROIT MICHIGAN 

ISRAEL GOLDIANOND PHD 

PROPESSOR OF PSYCHIATRY AND PSYCHOLOGY 
UNIVERSITY OF CHICAGO 
CHICAGO ILLINOIS 

♦JOAN GOLDSTEIN PHD 
RESEARCH SOCIOLOGIST 
GRADUATE CENTER 
CITY UNIVERSITY OF NEW YORK 
ADJUNCT PROFESSOR 
DEPARTMENT OP SOCIOLOGY 
BROOKLYN COLLEGE 
NEW YORK NEW YORK 

LOUIS J GOODMAN PHD 

DIRECTOR, DEPARTMENT OP STATISTICAL ANALYSIS 
CENTER FOB HEALTH SERVICES 
RESEARCH AND DEVELOPMENT 
AMERICAN MEDICAL ASSOCIATION 
CHICAGO ILLINOIS 

FRANK P GRAD LLB 
PROFESSOR OF LAW 
COLUMBIA LAW SCHOOL 
DIREC TOR 

LEGISLATIVE DRAPTING RESEARCH FUND 
COLUMBIA UNIVERSITY 
NEW YORK NEW YORK 

GARRETT HARDIN PHD 
PROFESSOR OP HUMAN ECOLOGY 
DEPARTMENT OF BIOLOGICAL SCIENCES 
UNIVERSITY OF CALIFORNIA 
SANTA BARBARA CALIFORNIA 

CLARK C HAVIGHURST 
PROFESSOR OF LAW 
DUKE UNIVERSITY SCHOOL OP LAW 
DURHAM NORTH CAROLINA 


* INDICATES PANELISTS WHO COMPLETED ADDITIONAL ASSIGNMENTS 


261 


♦RICH. X 3D b HELLER BD 
DIRECTOR, PRENATAL DIAGNOSTIC CENTER 
.-JOHNS HOPKINS HOSPITAL 
BALTIBCRE MARYLAND 

FOG33 BOSS HEBRIOTT PHD 
PROPESSOR 0? BI0CHS3I5T3Y 
SCHOOL OP HYGIENE AND P03LIC HEALTH 
JOHNS HOPKINS UNIVERSITY 
BALTIBORE BARYLAND 

STARa ROXANNE HILTZ PHD 

ASSOCIATE PROFESSOR AND CHAIRPERSON 

DE PA2TBS NT OP SOCIOLOGY 

DPSALA COLLEGE 

EAST ORANGE NSW JERSEY 

EALSTED R HOLBAN HD 
PROFESSOR OP BEDICINE 
DEPARTBS NT 0? BEDICINE 
STANFORD BSDICAL SCHOOL 
STANFORD CALIFORNIA 

PRANZ J INGLEPINGEH BD 
EDITOR 

SEW ENGLAND JOURNAL 0? BEDICINE 
BOSTON BASSACHOSETTS 

•JACQUELYNS JOHNSON JACKSON PHD 
ASSOCIATE PROPESSOR 0? BEDICAL SOCIOLOGY 
DEPARTBSNT OP PSYCHIATRY 
DO KE UNIVERSITY BEDICAL CENTER 
DORHAB NORTH CAROLINA 

ARTHUR J JACOBSON JD 

CLEARY. GOTTLIEB, STEEN, AND HABILTCN 
NEW YORK NEW YORK 

ANITA JOHNSON JD 
STAP? ATTORNEY 

PUBLIC CITIZENS HEALTH RESEARCH GROUP 
WASHINGTON DC 

•JEROME KAPLAN PHD 
EXECUTIVE DIRECTOR 
HANSPIELD BSaORIAL HOBBS INC 
ADJUNCT PROPESSOR OP SOCIOLOGY 
CHIO STATE UNIVERSITY 
HANSPIELD OHIO 

•SANDER KELHAN PHD 

ASSISTANT PROPESSOR 0? BEDICAL ECONOMICS 
SLCA3 PROGEAB IN HOSPITAL AND HEALTH SERVICES 
ADBINISTRATION 
CORNELL UNIVERSITY 
ITHACA NSW YORK 

PRANCES 0 KELSEY PHD HD 

DIRECTOR, SCIENTIFIC INVESTIGATIONS STAPP 

BUREAU CP DRUGS 

FOOD AND DRUG ADBINISTRATION 

ROCKVILLE BARYLAND 

GEORGE E KELSEY PHD DD 

PROFESSOR 0? CHRISTIAN ETHICS 

TEE THEOLOGICAL SCHOOL AND GRADUATE SCHOOL 

DREW UNIVERSITY 

MADISON NEW JERSEY 


BYRON KENNARD 
DIRECTOR 

NATIONAL COUNCIL FOF THE PUBLIC ASSESSMENT 
OF TECHNOLOGY 
WASHINGTON DC 

RONALD KOTULAK 
SCIENCE EDITOR 
CHICAGO TRIBUNE 
CHICAGO ILLINOIS 

JOHN C KRAMER HD 
ASSOCIATE PROFESSOR 

DEPARTMENT OF PSYCHIATRY AND HUMAN BEHAVIOR 

DEPARTMENT OP MEDICAL PHARMACOLOGY AND 

THERAPEUTICS 

UNIVERSITY OP CALIFORNIA 
IRVINE CALIFORNIA 

ALLAN H LAWSON 
EXECUTIVE DIRECTOR 

THE PRISONER'S RIGHTS COUNCIL INCORPORATED 
PHILADELPHIA PENNSYLVANIA 

CHAUNCEY D LEAKE PHD 
SENIOR LECTURER 
UNIVERSITY OF CALIFORNIA 

SAN FRANCISCO CALIFORNIA 

JEROME F LEAVELL JD 
PROPESSOR OF LAW 

MISSISSIPPI COLLEGE SCHOOL OF LAW 
CLINTON MISSISSIPPI 

BETSY LEVIN LLB 
PPOPESSOR OF LAW 
DUKE UNIVERSITY LAW SCHOOL 
DURHAM NORTH CAROLINA 

•THOMAS L LINCOLN HD 
SENIOR SCIENTIST 
THE RAND CORPORATION 
SANTA MONICA CALIFORNIA 

•R03ERT S LONDON BD 

CHIEF RESIDENT, OBSTETRICS AND GYNECOLOGY 
SINAI HOSPITAL OF BALTIMORE 
BALTIMORE HARYLAND 

CHARLES d LONG 

WILLI AH RAND KENAN JR PROPESSOR 
0? HISTORY OP RELIGIONS 
UNIVERSITY OP NORTH CAROLINA 
CHAPEL KILL NORTH CAROLINA 

•EDWARD L LONG, JR PHD 
PROPESSOR OF CHRISTIAN ETHICS 
THE THEOLOGICAL AND GRADUATE SCHOOLS 
DREW UNIVERSITY 
HADISON NEW JERSEY 

DONALD B LODRIA HD FACP 

PROPESSOR AND CHAIRHAN 

DEPARTMENT OP PREVENTATIVE BEDICINE 

NEW JERSEY BEDICAL SCHOOL 

NEWARK NEW JERSEY 


* INDICATES PANELISTS WHO COMPLETED ADDITIONAL ASSIGNMENTS 


262 


ROTH MACKLIN PHD 

INSTITUTE OP SOCIETY, ETHICS AND THE LIPE 
SCIENCES 

HASTINGS ON HODSON HEM YORK 

REVEREND VINCENT P M A IN ELL I HA 
ASSOCIATE DIRECTOR 

NATIONAL CONFERENCE OP CATHOLIC CHARITIES 
WASHINGTON DC 

CORA B BARRETT PHD 
ASSOCIATE PROFESSOR OP SOCIOLOGY 
UNIVERSITY OP WISCONSIN 
HADISON WISCONSIN 

RICHARD 0 KASOH PHD 
GRADUATE SCHOOL OP KANAGEHENT 
UNIVERSITY OP CALIFORNIA 
LOS ANGELES CALIFORNIA 

* WILLIAH E HAY PHD 

ASSOCIATE DEAN OF THE GRADUATE SCHOOL 

ASSOCIATE PROFESSOR 

SCHOOL OP RELIGION 

UNIVERSITY OF CALIFORNIA 

LOS ANGELES CALIFORNIA 

WILLIAM F BCGHAN PHARM C 
EXECUTIVE SECRETARY 

ACADEMY OF PHARMACEUTICAL SCIENCES 

OF THE AMERICAN PHARMACEUTICAL ASSOCIATION 
WASHINGTON DC 

MONSIGNOR JAMES T MCHUGH M DIV 
DIRECTOR, BISHOPS COMMITTEE FOR PRO-LIFE 
ACTIVITIES 

NATIONAL CONFERENCE OF CATHOLIC BISHOPS 
WASHINGTON DC 

♦CURTIS P MCLAUGHLIN DBA 
PROFESSOR OF BUSINESS ADMINISTRATION 
UNIVERSITY OF NORTH CAROLINA 
CHAPEL HILL NORTH CAROLINA 

SHEILA AVRIN MCLEAN LLB 
ASSOCIATE GENERAL COUNSEL 
FORD FOUNDATION 
NEW YORK NEW YORK 

♦JUDITH M HEARS 

SUPERVISING ATTORNEY AND CLINICAL 
TEACHING FELLOW 
YALE LAW SCHOOL 
HEW HAVEN CONNECTICUTT 

JANE E MERCER PHD 

ASSOCIATE PROFESSOR OF SOCI~’'' / "' 

DEPARTMENT OF SOCIOLOGY 
UNIVERSITY OF CALIFORNIA 
RIVERSIDE CALIFORNIA 

WILLIAM H MILLERD PHD 

RESEARCH ASSOCIATE AND POLICY ANALYST 
CENTER FOR SCIENCE IN THE PUBLIC INTEREST 
WASHINGTON DC 

KAREN W MULBAUSER 
EXECUTIVE DIRECTOR 

NATIONAL ABORTION RIGHTS ACTION LEAGUE 
WASHINGTON DC 


♦ROBERT F MURRAY JR KD MS 
PROFESSOR OF PEDIATRICS AND MEDICINE 
COLLEGE OF MEDICINE 
HOWARD UNIVERSITY 
WASHI NG TON DC 

♦DEBORAH MYERS 

ADMINISTRATIVE COORDINATOR AND 
LEGISLATIVE AGENT 

PRINCE GEORGE'S COUNTY COALITION FOR THE 
SUPPORT OF HANDICAPPED CHILDREN 
RIVERDALE MARYLAND 

ARYEH NEIER 
EXECUTIVE DIRECTOR 
AMERICAN CIVIL LIBERTIES UNION 
NEW YORK NEW YORK 

♦ROBERT C NEVILLE PHD 
PEOFESSOR OF PHILOSOPHY 

STATS UNIVERSITY OF NEW YORK AT PURCHASE 
PURCHASE NEW YORK 

BERNARD OKUN PHD 
PROFESSOR OF ECONOMICS 
BROOKLYN COLLEGE 
CITY UNIVERSITY OF NEW YORK 
NEW YORK NEW YORK 

JOSEPH N ONEK LLB 
DIRECTOR 

CENTER FOR LAW AND SOCIAL POLICY 
WASHINGTON DC 

LARRY I PALMER LLB 
ASSOCIATE PROFESSOR OF LAW 
CORNELL LAV SCHOOL 
ITHACA HEW YORK 

LISA R PEATTIE PHD 
PROFESSOR 

DEPARTMENT OF URBAN STUDIES AND PLANNING 
MASSACHUSETTS INSTITUTE OF TECHNOLOGY 
CAMBRIDGE MASSACHUSETTS 

LAWRENCE T PERERA 
JUDGE PROBATE COURT 
MIDDLESEX COUNTY 
CAMBRIDGE MASSACHUSETTS 

A ROBERT POLCARI MA 
EXECUTIVE SECRETARY 
NATIONAL INSTITUTES OF HEALTH 
BETHESDA MARYLAND 

E JAMES POTCHEN MD MS 

PROFESSOR OF HEALTH SYSTEMS MANAGEMENT 
PROFESSOR AND CHAIRMAN 
DEPARTMENT OF RADIOLOGY 
MICHIGAN STATE UNIVERSITY 
EAST LANSING MICHIGAN 

DANIEL A QUIRK JR PHD 
DIRECTOR OF PUBLIC POLICY 
NATIONAL COUNCIL ON THE AGING 
WASHINGTON DC 


♦ INDICATES PANELISTS WHO COMPLETED ADDITIONAL ASSIGNMENTS 


263 


SAMUEL RA5ISCVE LL3 
DIRECTOR. LEGAL DIVISION 

DEPARTMENT 0? I NT ERG ROUP RELATIONS AND 
SOCIAL ACTION 
AMERICAN JEWISH COMMITTEE 
NEW YORK NEW YORK 

JAMES RACHELS PHD 

ASSOCIATE PROFESSOR OP PHILOSOPHY 
UNIVERSITY 0? MIAMI 
CORAL GA3LES FLORIDA 

PA 33 1 EMANUEL PACKMAN LLS PHD 
R A 331, FIFTH AVENOE SYNAGOGUE 
PROFESSOR 0? JUDAIC STUDIES 
CITY UNIVERSITY OP NSW YORK 

JOHN A R0323TS0N JD 
ASSISTANT PROFESSOR 

UNIVERSITY OF WISCONSIN LAW SCHOOL 
MADISON WISCONSIN 

RICHARD 0 R03LIN III PHD 

ASSISTANT PROFESSOR 0? MICROBIOLOGY AND 
MOLECULAR GENETICS 
HARVARD MEDICAL SCHOOL 
ASSOCIATE BIOCHEMIST 
MASSACHUSETTS GENERAL HOSPITAL 
BOSTON MASSACHUSETTS 

CLARENCE E PUPE MD 

CHIEF OP MEDICINE 

ST JOHN HOSPITAL 

CLINICAL ASSOCIATE PROFESSOR 

DEPARTMENT OF MEDICINE 

WAYNE STATS UNIVERSITY 

DETROIT MICHIGAN 

ALFRED M SADLER JR MD 
DEPARTMENT OF MEDICINE 
MASSACHUSETTS GENERAL HOSFITAL 
BOSTON MASSACHUSETTS 

HAROLD M SCHMECK JR 
SCIENCE REPORTER 
WASHINGTON BUREAU 
NEW YORK TIMES 
WASHINGTON DC 

OLIVER SCHROEDER JR 
PROFESSOR OF LAW 

DIRECTOR THE LAW-MEDICINE CENTER 
CASE WESTERN RESERVE UNIVERSITY 
CLEVELAND OHIC 

RG3SFT SCHUYLER JR PHD 
MANAGER RESEARCH AND DEVELOPMENT 
DWS INCORPORATED 
PORTLAND OREGON 

* MICHAEL H SHAPIRO 
FROFESSOR OF LAW 

UNIVERSITY OF SOUTHERN CALIFORNIA 
LAW CENTER 

LOS ANGELES CALIFORNIA 

•MARGERY W SHAW MD JD 
DIRECTOR MEDICAL GENETICS CENTER 
UNIVERSITY OF TEXAS 
BCU5TGN TEXAS 


• INDICATES PANELISTS WHO COMPLETED ADDII ION AL AS 


DAVID H SMITH PHD 

ASSOCIATE PROPESSOR OP RELIGIOUS STUDIES 
INDIANA UNIVERSITY 
BLOOMINGTON INDIANA 

ROY SPEC2 
PROPESSOR OF LAW 
UNIVERSITY OF ARIZONA 
COLLEGE OP LAW 
TUCSON ARIZONA 

GABRIEL STICKLE 

VICE PRESIDENT POR PROGRAM PLANNING 
THE NATIONAL FOUNDATION-MARCH OF DIMES 
WHITE PLAINS NEW YORK 

•JUDITH P SWfcZEY PHD 

ASSOCIATE PROFESSOR DEPARTMENT OF SOCIO-MEDICAL 
SCIENCES 

BOSTON UNIVERSITY SCHOOL OF MEDICINE 
ASSOCIATE PROPESSOR GRADUATE FACULTY DEPARTMENT 
OP HISTORY 
BOSTON UNIVERSITY 
BOSTON MASSACHUSETTS 

•THOMAS S SZASZ MD 
PROFESSOR OF PSYCHIATRY 
STATE UNIVERSITY OF NEW YORK 
SYRACUSE NEW YORK 

GEORGE TARJAN MD 
PROFESSOR OP PSYCHIATRY 
SCHOOL OF MEDICINE 

UNIVERSITY OP CALIFORNIA AT LOS ANGELES 
LOS ANGELES CALIFORNIA 

LEO S TONKIN JD 
CHAIRMAN 

WASHINGTON WORKSHOPS FOUNDATION 
PRESIDENT, LEO S TONKIN ASSOCIATES 
WASHINGTON DC 

RICHARD P WAKEFIELD MCP 
PLANS AND PROCESS ANALYST 
CENTER POR STUDIES OP METROPOLITAN 
PROBLEMS 

NATIONAL INSTITUTE OF MENTAL HEALTH 
ROCKVILLE MARYLAND 

JON P. WALTZ JD 
PROPESSOR OF LAW 
NORTHWESTERS UNIVERSITY 
CHICAGO ILLINOIS 

SUE ALLEN WARREN PHD 

PROFESSOR AND CHAIRPERSON, DEPARTMENT OF 
SPECIAL EDUCATION 

PRESIDENT, AMERICAN ASSOCIATION OS MENTAL 
DEFICIENCY 
BOSTON UNIVERSITY 
BOSTON MASSACHUSETTS 

RICHARD WASSERSTROM LLB PHD 
PROFESSOR OF LAW AND PHILOSOPHY 
SCHOOL 0? LAW 
UNIVERSITY OF CALIFORNIA 
LOS ANGELES CALIFORNIA 


'UNDENTS. 


264 


♦RO 

3ERT S 

WEP 

? N 

ER P 

DI 

RECTOR 




DI 

VISION 

OF 

AD 

DICT 

UN 

IVERSITY 0 

F 

MIA (1 

MI 

AMI FLORID 

A 



HD 

ION SCIENCES 
I 


LUTHER S WILLIAMS PHD 
ASSOCIATE PROFESSOR OF BIOLCG Y 
FURDUE UNIVERSITY 
WEST LAFAYETTE INDIANA 


♦PRESTON N WILLIAMS PHD 

HOUGHTON PROFESSOR OF THEOLOGY AND CONTEMPORARY 
CHANGE 

ACTING DIRECTOR, W E 3 DUBOIS INSTITUTE 
HARVARD DIVINITY SCHOOL 
CAMBRIDGE MASSACHUSETTS 


♦MIRIAM G WILSON MD 
PROFESSOR OF PEDIATRICS 
CHIEF, GENETICS DIVISION 
DEPARTMENT OF PEDIATRICS 

UNIVERSITY OF SOUTHERN CALIFORNIA MEDICAL 
CENTER 

LOS ANGELES CALIFORNIA 


INDICATES PANELISTS WHO COMPLETED ADDITIONAL ASSIGNMENTS 


265 


Appendix 5: 

Descriptions of the Fifteen Advances 
and Six Scenarios included in the First 
Policy Evaluation Instrument. 






267 


ADVANCES IN SYSTEMATIC CONTROL OF BEHAVIOR 

Advance No. 1: Actions of Psyckopharmacological Agents Further Understood 

Laboratory and clinical psychopb.armacological research will 
generate new knowledge about how psychopharmacologic drugs 
affect mental activity and produce behavioral changes. More 
detailed and complete understanding of the mode of action of 
such drugs on neuromuscular and neurophysiological functions 
will facilitate the development of new drugs that produce desired 
mind-altering or behavioral effects specifically and predictably. 
For example, the mode of action of opiates may be understood 
sufficiently to allow a drug to be developed that has power- 
ful analgesic properties but with its consciousness-altering 
and addictive properties eliminated or reduced. 


Advance No. 2: Do-it-yourself Anxiety and Tension Reduction 

A preprogrammed, automated technique for teaching deep 
muscle relaxation as a means of anxiety and tension reduction 
will be developed as a result of parametric research. The 
result of such research will be the specification of the type 
of materials to be presented, their order or presentation, 
and the number required to reduce anxiety and tension in a 
given population. 

The automated package will consist of a tape recorder and 
seven tapes, containing step-by-step instructions to the 
listener. In three one-half hour segments the listener would 
be taught, in a doctor’s office, classroom, or in the privacy 
of his/her home, how to achieve a state of deep relaxation 
and emotional calm by systematically tensing and relaxing 
major body muscle groups and areas, i.e., arms and hands, 
feet and legs, facial muscles, breathing. Following these 
first three sessions — heard on three consecutive days — 
the listener would then follow the directions on the four 
remaining tapes — each of which would be listened to on 
succeeding days also. The last four tapes would enable the 
listener to achieve a state of deep relaxation in an increas- 
ingly shorter time. Separate packages might be developed 
for different population groups; e.g., adults, children. 

While the technique night be prescribed by health professionals, 
it would be self-administered and cost about $100 to purchase. 

It could be applied on a wide scale not only by persons under 
constant stress (physicians, lawyers, executives, etc.) but 
could also be applied as part of a mental hygiene program in 
schools to teach children healthy means of dealing with 
tension. 


268 


dvance No. 3: More Predictable Psychosurgical Procedures 

Advancing knowledge from animal and clinical studies about 
brain structure and functions, and the definition of psycho- 
surgery as an experimental treatment, subject to rigorous 
design and evaluation requirements, will lead to the develop- 
ment of more predictable and precise psychosurgical procedures 
capable of effecting specific behavioral changes. 

The use of more precise psychosurgical procedures for defined 
types of behavioral alterations will probably take place on 
a small scale, in relatively few clinical centers. This 
behavior change technology will be administered by neuro- 
surgeons, with psychiatrists, neurologists, and related 
specialists involved in evaluative studies. As an investi- 
gative procedure, the uncertainty factor, including physical 
risk, will be high. 


269 


ADVANCES IN REPRODUCTIVE ENGINEERING 

Advance No. 1: In-vitro Fertilization Available in Clinical Practice 

Infertility due to various common disorders causing bilateral 
Fallopian tube occlusion will remain a problem, one that will 
be treated by in-vitro fertilization. 

In-vitro fertilization consists of fertilizing an egg with 
a sperm outside the human body, with the resultant embryo 
(fertilized egg) implanted in a recipient uterus where it 
grows and develops normally. 

Eggs are obtained using a simple surgical procedure, and 
placed in culture; sperm are then added. A few days later, 
using a syringe introduced through the vagina, the resultant 
embryo is implanted into the recipient uterus. Proper hormonal 
balance in the lining of the uterus is required for implanta- 
tion. 

The several steps involved in in-vitro fertilization will take 
place in hospitals and will be carried out by physicians 
supported by specially trained technicians. The cost of 
in-vitro fertilization will be relatively high, about $1,000. 

Advance No. 2: Sex Selection by Sperm Separation 

The X-sperm (female producing) and Y-sperm (male producing) 
present in semen can be separated in the laboratory using a 
filtration process. 

Semen is allowed to pass through a special filter. The smaller 
and more round-headed Y-sperm pass more readily through the 
filter than do the larger more elongate-headed X-sperm. The 
spearated sperm are collected and the appropriate fraction 
(X-sperm or Y-sperm) used for artificial insemination. 

Filtration does not completely separate sperm, rather it 
greatly increases the concentration of one type of sperm to 
93%. Moreover, recovery of Y-sperm is easier than X-sperm, and 
therefore conception results more often after artificial insemi- 
nation of enriched Y-sperm semen than of enriched X-sperm 
semen. 

Sex selection by sperm filtration is carried out by trained 
technicians under the guidance of a physician and requires 
attendance at a hospital or clinic. The specific procedure 
costs about $350. 

A.dvance No. 3: Safe 3 Simple Medical Sterilization Available 

A safe and effective medication for sterilizing women will 
be developed. The medication permanently prevents reproduction 


270 


after one injection, would be administered by para-medical 
personnel with limited training, and will cost about $10.00 
per shot. Physical risk from the medication is less than 
that from routine abortion. Moreover, women receiving the 
medication show no changes in appearance and sexuality is 
unimpaired . 


271 


ADVANCES IN GENETIC SCREENING 

Advance No. 1: Amniocentesis Becomes Routine 

Amniocentesis, which allows the physician to detect chromosome 
anomolies in an unborn child, will become a routine part of 
prenatal evaluation, particularly in women over 35 for whom 
the risk of bearing an affected child increases markedly. 

Amniocentesis involves withdrawing a small quantity of the 
fluid that surrounds the fetus by introducing a hollow needle 
into the uterus through the pregnant woman’s abdomen. Fetal 
cells contained in the fluid are cultured in a central labora- 
tory and a chromosomal assessment made. 

A fetus with a chromosome anomaly, as would be the case in 
Down's Syndrome (Mongolism), for example, could be selectively 
aborted, thus preventing the condition. The technique can 
also be used to determine the sex of an unborn child. 

Testing, which is technically simple, will be done by physi- 
cians or trained technicians. The risk of physical harm to 
the mother is minimized, and to the fetus is virtually 
nonexistent. Reliability is high; there are few false 
diagnoses. 

Amniocentesis will be relatively inexpensive, costing between 
$50 and $100 per test. 


Advance No. 2: Widespread Screening for Inborn trrors of Metabolism 

The development of automated methods of biochemical analysis 
will make it possible to identify the carriers of genes that 
determine autosomal recessive traits. There will be simul- 
taneous testing for many, 50 or more, metabolic errors that 
are commonly carried (1 in 61 persons) but that rarely mani- 
fest themselves (1 in 15,000 persons) because a child born to 
two persons with the trait has only a 1 in 4 chance of being 
affected . 

These analyses, which will be performed on blood serum and 
red cells, urine, and other body fluids, will allow the entire 
population to be screened ana allow carriers to be given 
genetic counseling. 

Testing will cost $5.00 to $15.00 per person, depending on 
the number of tests performed, and carries minimal physical 
risks. It will be applied or supervised by physicians. 


Advance No. 3: Research. Shous Lung Cancer Heart Disease have Genetic Basis 

The genetic basis will be discovered for variations in the 


272 


susceptibility of individuals to common conditions, such as 
lung cancer and heart disease. Such discoveries will go a 
long way to explaining why not all cigarette smokers, for 
example, succumb to lung cancer. Simple biochemical tests 
such as those for certain configurations of tissue antigens, 
will allow the assessment of an individual's susceptability to 
certain diseases in which behavioral or environmental factors 
play an important etiological part — lung cancer in cigarette 
smokers, for example. 

Tests to assess an individual's susceptibility to such 
conditions will cost about $25.00 each and be performed by a 
technician in a doctor's office or clinic. Testing will 
involve no physical risk. 


273 


ADVANCES IN EXTENSION OF LIFE 

Advance No. 1: Compact 3 Wearable j Artificial Kidney Developed 

On-going research will result in the development of an artifi- 
cial kidney small enough to be worn in back-pack style. 

Moreover, problems of using dialysis machines, such as the 
maintenance of the site at which the tubes that circulate the 
patients' blood through the machine enter the body, will be 
solved, making an artificial kidney a practical replacement 
device. 

The development of an artificial kidney will greatly improve 
the treatment of chronic renal failure and provide a viable 
alternative to kidney transplantation. However, initial invest- 
ment costs will be relatively high. Although treatment with 
an artificial kidney will remain relatively expensive, it will 
probably cost less than present techniques like chronic renal 
dialysis which currently costs between $20,000 and $40,000 
per patient per year. 


Advance No. 2: Environmental Causes of Disease and Trauma Further Controlled 

Epidemiological and clinical research will increase our under- 
standing of the causative factors associated with specific 
diseases and with life threatening accidents and trauma. 

Removal of certain substances from the environment, such as 
chemicals known to cause cancer, can reasonably be expected 
to extend life. Knowledge about the causes of accidents may 
allow us to redesign products so that they become less of a 
life-threatening hazard. 

In certain instances we may find adding substances to the 
environment beneficial. The addition of fluoride to water 
and iodine to salt, are aimed at reducing or preventing certain 
diseases (dental cavities and goiter, respectively). Future 
possibilities include, for example, antioxidants which could 
be added to food to retard the aging process, and the addition 
of vitamins to alcoholic beverages to reduce the incidence of 
alcoholic neuropathies. 

The cost of altering or adding specific factors to the environ- 
ment or removing them from it will vary greatly. The cost of 
removing a substance widespread in the environment would 
obviously be high, while the cost of redesigning products would 
depend on the particular circumstance. Inconvenience and 
restricted use might also occur. The cost of adding substances 
to the environment would again vary with the degree of use. 
Additional costs would be incurred if the substance was 
universally incorporated into a food, for example, even though 
only a small proportion of the population would benefit as a 
result . 


274 


Advance do. 3: Gem Therapy Now Available 

There are a number of genetic diseases, labeled collectively 
"inborn errors of metabolism," which result from the absence 
or severe reduction in the patient of a particular enzyme. 

Disease is caused in these cases either through the accumulation 
of the substance which the enzyme is supposed to destroy or 
convert, or by reducing the availability of the product of 
the enzyme's reaction. 

The deficiency of particular enzymes will be overcome through 
gene therapy. Microbiologists working with viruses that bear 
the deficient enzyme will literally replace the missing genetic 
information in a human cell simply by giving the patient a viral 
infection. The virus will then transmit to the human the genetic 
information necessary to make the enzyme. The long term 
effects of adding genetic material to the patient's cells may 
only be learned as a result of life-long follow-up, and possibly 
only after life-long follow-up of his or her descendents. 

Possible consequences include the development of cancer in 
later life and the alteration of germ cells which could affect 
subsequent generations in unknown ways. 

The cost of gene therapy, once developed, would be less than 
current methods of patient management, such as endocrine replace- 
ment therapy. Such treatments would be delivered by specialized 
physicians and scientists working in major hospitals. 


275 


ADVANCES IN DATA BANKS, COMPUTER TECHNOLOGY 

Advance No. 1: Computerized lledica l Records in Use 

The advent of large data storage devices, inexpensive data 
retrieval devices, and sophisticated programming will result 
in the computerization of the medical record. Application of 
this technology within the next 20 years will mean that at 
the end of this period approximately 80% of the U.S. population 
will have medical records that are computerized. 

Although separate computerized medical records will still 
be maintained on individuals by each service provider (hospital 
or physician, for example) this data could be accessed remotely 
if required. Moreover, records on related individuals could be 
linked together so that the provision of family care, for 
example, could be facilitated. 

Additionally, each person could be given a copy of his 
or her medical record on a small computer tape cassette that 
could be transferred from institution to institution. 

The use of such computer technology will increase the 
completeness of each individual's medical record. Adoption 
of a standard record format would facilitate the process of 
building a complete medical record. 

Apart from any improvement in medical practice brought 
about by more complete medical records, such records can be 
used for medical care quality assurance programs and also for 
research purposes. Data from the records of patients treated 
by the same physician could be aggregated and used to assess 
his or her performance. The analysis of very large bodies of 
data are often required for disentangling the genetic, environ- 
mental and other factors influencing the etiology of disease 
processes and conditions. Also to be considered is the variation 
in the response of individuals to different treatments. A 
person’s life-long computerized medical records would doubtless 
be a rich source of data for such research. 

The cost of maintaining an electronic, computerized, patient 
record will be less than maintaining the traditional paper file. 


Advance No. 2\ Computer simulates metabolic processes j o.ids patients 

Increased understanding of the physiological and pathological 
processes of organ systems will be embodied in computer models 
that will be able to simulate them. The successful simulation 
of such processes will enable computer controlled management 
of organs or organ replacements. Computer controlled patient 
management will first be applied in intensive care. Minia- 
turization and improved electronics will allow certain organs 
or organ replacements (kidney, limbs, etc.) to be managed by 


276 


computer in the ambulatory patient, virtually maintenance free. 
Physicians and other specially trained technicians will be 
required for fitting and monitoring such devices, and for 
computer controlled patient management. The cost of such 
devices, or of simply managing an organ by computer, will 
remain relatively high as they will not be mass produced. 

Advance No. 3: Computer screens patients 3 provides check-ups 

Regular health check-up will be provided by paramedical person- 
nel using computers. Individuals going to a local doctor's 
office, clinic, or screening center will interact with a 
computer via a video-terminal . The computer will take a medi- 
cal history or ask pertinent questions. Based on an analysis 
of patients' responses to these questions and on data about 
body functions provided by special sensors and tests, the 
computer will warn of impending illness or state changes, offer 
preliminary diagnoses, or suggest certain treatments or 
actions. Such computer-aided screening, diagnosis, and testing 
will cost about $20.00 per application, and could provide the 
physician with a valuable adjunct for diagnosing, treating, 
and managing the health of his/her patients. 


277 


SCENARIOS 


Scenario . 7 o. 

1: Select-A-Boy, Select- A-Girl Marketable Kits 

The XYZ company has developed a safe and effective method for 
preselecting the sex of one’s children. The method consists of 
a vaginal douche and foam used prior to intercourse. The 
separate preparations, douche and foam, have been extensively 
tested and are without significant side-effects. The use 
of the method does reduce fertility — on the average, couples 
would have to try three times as long to conceive as they would 
without the use of the preparations. If the woman does con- 
ceive, however, 97 of every 100 pregnancies will produce a 
child of the desired sex. The incidence of congenital mal- 
formations in babies born to mothers using the method is no 
higher than those born normally. The XYZ drug company has 
decided to market the foam and douche under the brand names 
Select-a-Boy" and "Select-a-Girl" . These moderately priced 
kits will be marketed through drugstores, and will contain: a 

detailed book of instructions about using the preparations and 
timing sexual intercourse to maximally ensure conception; 
reasons for infertility; an educational packet on family plan-^ 
ning, added after intense lobbying by a group dedicated to 
zero population growth. Should XYZ company be allowed to 
market the kit? 

Option 1: 

The XYZ Company should be allowed to market the kit. 

Option 2: 

The XYZ Company should not be allowed to market the kit. 


Scenario No. 

2: Hospital Responsibility for Physician Performance Data 


Dr. de Best, a respected surgeon nearing retirement age and 
Chairman of the University Hospital’s Department of Surgery, 
performs an established surgical procedure on John Doe. 

Mr. Doe’s operation is uneventful and he is discharged from 
the hospital. Some short time later he develops great abdominal 
pain and is rushed to the hospital where he dies. An autopsy 
shows Mr. Doe died as a result of an unquestionably poor surgi- 
cal technique by Dr. de Best. Mrs. Doe blames the hospital 
for his death and seeks help from a public interest law firm. 

Ms. Good, the lawyer to whom she is referred, learns that the 
research unit of the University Hospital conducts periodic 
studies of physicians' performance. Ms. Good secures a copy 
of the most recent report (which was conducted sometime prior 
to Mr. Doe's operation). The data shows that over a two year 
period, ten patients on whom Dr. de Best performed the same 
surgical procedure probably died as a result of negligence on 
his part. On further investigation, Ms. Good finds that 
these results were known to the hospital administration and 
board. Dr. de Best has died since the surgery was performed. 


278 


Option 1: 
Option 2: 

Scenario 


Option 1: 
Option 2: 

Scenario 


so legal suits are brought on Mrs. Doe's behalf by Ms. Good 
against the hospital for not informing Dr. de Best's prospec- 
tive patients of Dr. de Best's record. 

Should hospitals be held responsible for informing prospec- 
tive patients about data on physician performance? 


Hospitals should be responsible for informing prospective 
patients about data on physician performance. 

Hospitals should not be responsible for informing prospec- 
tive patients about data on physician performance. 


No. 3: Drug Treatment for Prisoners 

A highly successful drug is available that provides the reduc- 
tion of aggressive and assertive behavior on the part of 
individuals taking it. No significant side effects have been 
established after clinical trials of 3-5 years duration. 

Users of the drug become conditioned to a nonassertive behavior 
pattern and can terminate use after a year of treatment but 
retain the behavior brought about by the drug. The drug is 
given in doses which allow for sufficient aggression to be 
maintained for coping with stressful societal conditions. 

A state prison system wishes to offer this treatment on a 
voluntary basis to prisoners who crimes involved aggressive 
behavior, as judged by a medical review board on an individual 
case basis. The treatment costs approximately $1.00 per patient 
day. Prisoners accepting the treatment could be granted a 
parole if they are successfully treated by the drug while the 
sentences of those choosing not to participate will be unaffected. 
Should such a program be allowed? 


The treatment of prisoners with the drug should be allowed. 

The treatment of prisoners with the drug should not be 
allowed . 


No. 4: Allocation of Health Services Funds 

A mid-sized city has received funds to expand its health 
services, with the proviso that the funds be used for capital 
improvements or equipment only. Two groups are in competition 
for the use of these funds. The first is the local teaching and 


279 


Option 1: 
Option 2: 

Scenario 


university hospital which is lobbying for a sophisticated, 
computerized, diagnostic machine. Previous research and appli- 
cation have demonstrated that this equipment can serve to 
improve the acute diagnosis of intracranial lesions, reduce 
side effects of current procedures, and possibly reduce mortality 
by early diagnosis. It would also provide urgently required 
data for research into certain illnesses (brain damage, cancer, 
etc.). The equipment would be the only set-up of its kind in 
the region and would be used in the diagnosis of approximately 

10.000 persons per year. Without this equipment approximately 

1.000 persons would die each year because their conditions 
would not be diagnosed in time for life-saving surgery to be 
performed. The number of persons benefiting from the research 
data provided is difficult to determine, although a study to 
estimate this is planned. 

On the other hand, there is a second group which insists 
that the funds be used to construct a neighborhood health 
clinic in the densely populated and lower-income section of the 
city that currently has no such facility. This clinic would 
provide acute care services for approximately 30,000 persons 
each year. This additional care would result in reducing the 
infant mortality rate and aid in early detection of treatable 
diseases . 

The construction costs for both projects are equivalent. 

Should the funds be awarded to the university hospital, or 
the neighborhood health clinic? 


The University Hospital receives the funds. 

The Neighborhood Health Clinic receives the funds. 


No. 5: Marketing of a Group Insurance Flan with Genetic Screening 

An insurance company has developed a new family plan that 
offers exceptionally wide coverage at a substantially reduced 
rate. The plan, however, is only able to provide such cover- 
age because enrollees must meet certain criteria, one of which 
is to undergo genetic screening. It also requires that any 
fetus of enrollees undergo genetic screening and prenatal 
diagnostic checks. Additionally, if the screening or tests 
indicate that the fetus is afflicted with any disorder likely 
to require extensive, life-long care, it is to be aborted. 
Non-compliance will mean ineligibility for further prenatal 
or postnatal care for either mother or child. 

The company applies to an insurance commissioner for permission 
to offer this plan in his state. The insurance commissioner 
denies the application, contending that it discriminates 
against those with genetic defects and those who object to 


280 


Option 1 
Option 2: 

Sceno.rio 


Option 1 
Option 2 


genetic screening. He also asserts that individuals cannot 
be obligated to undergo genetic screening as might be the 
case if employers select the option as a group plan. A public 
interest group protests this decision on the grounds that it 
interferes with fair marketing practices, and that otherwise 
qualified individuals who choose to undergo the genetic 
screening in order to be eligible for reduced rates should be 
allowed to do so. Should the company be allowed to market 
the plan? 


The Insurance Commissioner should approve marketing of the 
plan. 

The Insurance Commissioner should not approve marketing of 
the plan. 


No. 6: Life ov Death Decision 

Mr. Smith, a 26 year old social worker, has been in a coma 
for 3 weeks in the local hospital where he is being treated 
for severe trauma. The doctors think that there is only about 
30% chance of his coming out of the coma and his health being 
largely restored; he would perhaps have to be sustained on the 
life saving equipment for two to three months. The issue is 
brought to a head with admission of an accident victim, a 
52 year old university professor who needs the same equipment 
and who has a better than 50% probability of survival. He 
must use the equipment at this hospital, for if he is trans- 
ported to another one, he would almost surely die. 

Mr. Smith's family insists that the question of removing the 
equipment be decided by the physician in charge of the Inten- 
sive Care Unit (ICU) after he consults with each patient's 
family physician. The family of the university professor 
asserts that the only just resolution is to have a panel, 
perhaps consisting of the ICU physician, both family physi- 
cians, and three persons appointed by the hospital (a physi- 
cian, an attorney, and one other person) make the decision. 
They contend it is more than a personal, "first come first 
served" question; that it is a community question. 

Everyone realizes that this decision will set a precedent for 
this hospital, and for other hospitals in the area. Who 
should decide? 


The ICU physician should decide. 

The panel of persons should decide. 


281 


Appendix 6: 

Descriptions of the Four Policy 
Scenarios included in the Third 
Policy Evaluation Instrument. 






POLICY SCENARIO NO 1: PERMANENT NATIONAL COMMISSION 


01 A permanent National Commission on Biomedical and Behavior- 
al Research and Technology (the Commission) was established 
under the Biomedical and Behavioral Research and Technology 
Act (the Act). The Commission is an independent organiza- 
tion funded by and reporting to the U,S 0 Congress. The Act 
authorized the operation of the Commission for a period of 
20 years.. At the end of this period, the Commission would 
be abolished and its functions cease unless authorized by a 
new act, 

02 The purpose of the Commission is to optimize the benefits 
and costs to society of biomedical and behavioral research 
and technology,, The Act gave the Commission jurisdiction 
over all aspects of biomedical and behavioral research and 
the implementation of resultant technologies, plus the 
duty to recommend priorities to Congress for approval and 
for fundingo The Commission acts at the national policy 
level, promulgating guidelines, regulations, and defini- 
tions, These guidelines, etc,, are enforced through var- 
ious incentives and penalties prescribed by the Act. In 
all cases, the Commission's rulings are final, unless 
amended by an Act of Congress, or by the courts. Its ru- 
lings are implemented by the Executive Branch of the fed- 
eral government (specifically, DHEW) c 


03 The Commission has 15 full-time salaried members: 7 scien- 

tists and researchers, 7 nonscientists and nonresearchers, 
and a chairperson who must be a nonscientist/nonresearcher . 
Nominations to the Commission are made by the President; 
however. Congress actually appoints the commissioners and 
selects the chairperson The President provides the names 
and qualifications of twice as many persons as are required. 
The appropriate committees in the House and in the Senate 
then select from that list. Differences about appointments 
are resolved by the chairpersons of the committees. All 
nominations may be rejected; the President must then sub- 
mit a new list of qualified individuals. 


04 


Commissioners serve three year, nonrenewable terms. At the 
beginning, five members were appointed for one year, five for 
two years, and five for three years. Scientists/researchers 
are replaced by other scientists/researchers, and the same 
holds true for nonscientists/nonresearchers. There are no 
special restrictions on commissioners except direct or indirect 
conflicts of interest. Similarly, there are no special quotas 

0 representation for commissioners (e.g., behavioral scientists 

1 l eTS l - ethlclsts > etc -)> although the Act specified that 
membership must be as representative as possible. A resume 
Statement of Qualifications, and Conflict of Interest State- 
ment for each commissioner are available to the public, either 

ree by inspection, or on payment of a reproduction fee if a 
copy is requested. 


284 


05 The Commission employs a staff divided into departments, to 
support its functions, prepare materials for review, etc. 

06 The Commission formulates and promulgates policies, guide- 
lines, and regulations pertaining to biomedical and behavior- 
al research and technology, and it is also responsible for 
promulgating pertinent definitions (such as the point at 
which life ceases in a human being) . The Commission con- 
cerns itself only with major policies, guidelines, regula- 
tions, and definitions. Federal agencies, review boards, 
and other agencies are responsible for interpreting them 

and providing detailed directives . 

07 Although the Commission must approve (i.e„, promulgate) all 
policies, guide-lines, definitions, etc., federal agencies 
(such as FDA, FTC, etc.), professional societies, or other 
groups with expertise in specific areas may draw-up guide- 
lines, regulations, definitions, etc., and submit them to 
the Commission for approval. In some cases, the Commission 
may conduct special studies prior to promulgating guidelines, 
etc . 

08 The Commission decides on cases submitted to it for appeal, 
such as those submitted by researchers whose proposals re- 
ceived an adverse ruling from review boards. In order to 
determine if a case should be considered by the Commission, 
it is first reviewed by a panel consisting of three Commis- 
sioners, at least one of whom is a scient ist/researcher , and 
one a nonscientist/nonresearcher „ Only those cases consid- 
ered to be precedent-setting are sent to the Commission. 

09 The Commission annually audits a random sample of biomedical 

and behavioral research projects conducted with public funds, 
and reports on such factors as: the extent to which the pro- 

ject was conducted in accordance with the proposed work, in- 
cluding protection of human subjects; the scientific sound- 
ness of the methodology with which the project was conducted; 
the validity of "knowledge" gained as a result of the project. 
The results of these audits are available to the general pub- 
lic in a report written in lay language. 

10 The Commission is responsible for formulating a national 
strategy on public funding of biomedical and behavioral re- 
search and the implementation of resultant technologies, 
including the proposal of priorities. This national strat- 
egy is reviewed every two years. As part of this review, 
the Commission will consider the work of federal agencies 
charged with dispensing funds, in order to determine the 
extent to which national strategy directions were followed. 
The Commission is also responsible for collecting data re- 
garding expenditures for biomedical and behavioral research 
(public and private). The appropriate categories to be used 
by federal agencies for reporting such expenditures are de- 


285 


termined by the Commission to facilitate the collection of 
meaningful data. Every two years, the Commission recommends 
this national strategy, including priorities, to the Congress 
for approval and funding. 

11 Ninety percent of federal funds for biomedical and behavior- 
al research projects are allocated to those projects express- 
ly related to the national strategy. In order to encourage 
innovative and creative research not necessarily related to 
present-day priorities, the remaining ten percent is placed 
in a special fund. Researchers may submit proposals to ob- 
tain these funds in designated categories of research (e.g., 
technology development, technology application). There is 

a ceiling on the amount of funds that can be requested for 
a research project under this category. The categories and 
ceilings are determined by the Commission in a biennial re- 
view. Proposals are screened for scientific merit (to rule 
out truly unworkable projects) by a peer-review panel. 
Acceptable proposals are given a serial number. Every three 
months serial numbers are drawn randomly until the amount 
in that research category for the quarter has been allocated. 
Proposals selected for funding must observe all Commission 
guidelines pertaining to research projects. Unsuccessful 
proposals are included in the next three drawings, and then 
withdrawn. Researchers may not submit more than one propo- 
sal per quarter in each category. A researcher whose pro- 
posal is turned down for inclusion in the drawing may appeal 
the decision to a panel operated by the Commission. 

12 The Commission meets as often as necessary to accomplish its 
functions. However, it must hieet at least weekly to discuss 
or adopt policies, reports, etc. Although the Commission 

is based in Washington, D.C., at least once each month it 
meets in a different location. These meetings are usually 
held in DHEW regional offices or at the Centers. All meet- 
ings are open to the public. A transcript is made of each 
meeting, and the proceedings are summarized. Summaries 
and transcripts are available to the public on a subscription 
basis or may be inspected at the Commission’s office, or at 
various repositories such as DHEW and other federal govern- 
ment offices. 

13 The Commission is required to take a roll call vote to adopt 
policies, guidelines, definitions, reports, etc. A simple 
majority is needed for adoption. Minority views on an issue 
are reported after the vote has been taken. Votes of the 
Commission and minority views are published in the proceed- 
ings and in the report on the subject to which the vote per- 
tains. Issues to be addressed by the Commission, such as 
the revision of a definition (e.g., the point at which life 
ceases in a human being), are announced in the Federal Reg- 
ister 30 days prior to the start of the Commission’s deliber- 
ations on the subject. The period of deliberations is 60 
days. During this time, testimony may be heard or sent in. 


286 


Staff papers on the subject and those requested from or 
submitted by professional organizations, contractors, etc. 
are also reviewed by the Commission during this period. 

Within the next 30 days, the Commission publishes its first 
report. This report contains its recommendations on the 
issue (e.g., a definition), along with any testimony, papers, 
etc. Interested gorups or individuals are then given 60 
days to comment on the report. Within 30 days following 
this period, the Commission must publish its final report. 
This report contains its ruling on the issue and any com- 
ments received in response to the first report. The final 
report, therefore, establishes policy. 

14 The Commission maintains a repository of its policies, guide- 
lines, and regulations pertaining to biomedical and behavior- 
al research and technology. These policies, etc., which are 
open for public inspection, are written in a form understand- 
able by lay persons], Key aspects of the policies, etc., are 
actively disseminated to the general public through the 
media. Organizations, scientists, and researchers can re- 
ceive a copy of these policies, etc., simply by asking to be 
placed on a mailing list. They are automatically sent to 
review boards and panels. 

15 All policies, guidelines, regulations, and definitions apply 
to individuals, private (for-profit and non-profit) and pub- 
lic organizations, whether or not they use public, funds for 
their research. 

16 The Act provided penalties for persons or organizations who 
infringe Commission policies, guidelines, regulations, etc. 
Depending on the severity of the infringement, or if it was 
willful or criminally negligent, the Commission can censure 
the person involved; prevent him/her from receiving federal 
funds for research or for the treatment of patients; refer 
the case to the appropriate professional licensing authority; 
or refer the case to the Justice Department for prosecution. 
Such penalties apply to those regulated (e.g., researchers, 
practitioners, etc.), and to the regulators (e.g., federal 
employees or private organizations that perform reviews, 
assessments, evaluations, etc., on behalf of the Commission). 

17 Every four years the Commission evaluates the effectiveness 
of its own policies, regulations, guidelines, etc., or those 
of subordinate agencies, to ensure that such policies serve 
the purposes for which they were designed and that the pur- 
poses themselves are still appropriate. An outside organi- 
zation is selected by the Commission to carry out this eval- 
uation. The organization's report is published. The Commis- 
sion debates the report, and issues a report on problems 
which have been revealed, and what should be done about them. 


287 


18 The work of the Commission is evaluated by the Congress 

every two years. The basis for this evaluation includes, 
but is not limited to, the following: written reports 

available to the public; open hearings held by Congress- 
ional committees; and special studies requested by Con- 
gress. 

19 The Commission publishes an annual report to Congress, 
summarizing the year’s activities, and the findings of the 
reports it issued during that year. 


288 


POLICY SCENARIO NO 2: PUBLIC INVOLVEMENT IN POLICY DECISION-MAKING 

01 Several provisions of the Act setting up the Commission were 
written to encourage and facilitate public involvement in 
policy decision-making with respect to biomedical and be- 
havioral research and technology, and to inform the public 
on these subjects . Public involvement was achieved through 
the structure and operation of the Commission itself, re- 
view boards (see Scenario No„ 3), and through the creation 
of five public information centers. 

02 All meetings of the Commission are open to the public. In- 
dividuals and groups are encouraged to comment on proposed 
policies, guidelines, regulations, etc., at every stage of 
their formulation. They are able to participate in debates 
of the Commission on issues being addressed by it, present- 
ing either oral or written testimony. A repository of all 
policies, etc., in effect is maintained by the Commission 
and copies may be inspected or obtained by the public 

(see Scenario No.l). An approved research proposal may al- 
so be inspected or obtained by the public (see Scenario No. 
3). All assessments of technologies are published (see 
Scenario No. 4). Reports on the Commission's activities 
are published annually. 

03 The Commission is responsible for informing the public 
generally about the implications of biomedical and behavior- 
al research and the implementation of the resultant technol- 
ogies. To this end, it supervises a number of information 
services, and conducts media campaigns. Through these 
mechanisms the Commission disseminates its findings and 
those of the reports it issues, prepared by itself or others 
on its behalf. 

04 The Commission conducts studies of the implication of ad- 
vances in biomedical and behavioral research and technology, 
and makes its findings known to the public through reports 
on the studies, its information service, and the media, if 
appropriate. 

05 The Commission sets standards detailing the nature and ex- 
tent of information which marketers of biomedical and be- 
havioral products and services must provide to consumers 
about the bad (as well as the good) effects of these pro- 
ducts and services, and how this information is to be pre- 
sented, e.g. on the product packaging, at place of sale, 

or through the media (with advertisements). The Commission 
can also specify that a certain proportion of a marketer's 
revenues be used to give such information to the public. 

06 On matters the Commission holds to be especially important, 
a survey of national opinion may be undertaken and the re- 
sults published prior to the Commission voting on the issue. 


239 


The Commission also conducts surveys of national opinion to 
evaluate its own activities and decisions and to see how its 
effectiveness is perceived by the public. The results of 
these surveys are also published. 

07 The Act created five independent Biomedical and Behavioral 
Research and Implementation Information Centers (the 
Centers). These five Centers were selected by the National 
Commission on the basis of competition and geographical rep- 
resentation. In order to encourage creativity and diver- 
sity, only new not-for-profit organizations were eligible. 
(Universities and other existing public and private organ- 
izations were ineligible, although they could join in a 
coalition that resulted in a new, legally separate entity.) 

03 An entity wishing to become a Center had to prepare a pro- 
posal adhering to an outline provided by the Commission. 

Each proposal was published and subjected to public debate. 
Finally, the Commission designated five organizations as 
Centers. 

09 Each Center is a legal entity with a Board of Trustees and 
an Executive Staff. Composition of the board and selection 
of members is the responsibility of each organization. 

The Board of each Center is responsible for determining the 
Center policy, selecting staff, etc. 

10 Each Center receives $6 million annually from the Congres- 
sional appropriation that supports the Commission. Although 
the Centers file an annual work plan with the Commission, 
each Center is free to develop the programs and projects 
aimed at public participation that it deems appropriate. 
Also, Centers are free to solicit contributions from the 
general public. Contributions, however, are limited to a 
maximum of $1,000 per person per year. Only persons aged 

18 years and older may contribute; organizations may not. 

11 Centers have the following purposes: to monitor research 

and technology directions in their region; to foster the 
implementation of policies and regulations; to assess pub- 
lic opinion and understanding; to disseminate information 
to the public; and to engage in other public participation 
activities (such as forums, debates, question-answer ser- 
vices, etc.). 

12 Every two years the work of each Center is reviewed by the 
Commission in open public hearings. Citizens groups and 
individuals are invited to comment on the Centers. Each 
Center may comment on the activities of the others. New 
applications from groups who want to form a Center are 
also reviewed, and the Commission is free to replace an 
established Center with a new one if this would diversify 
the constituencies represented or if an old Center is 
found to be deficient. (The total number of Centers, 
however, remains at five.) 


290 


POLICY SCENARIO No 3: BIOMEDICAL AND BEHAVIORAL RESEARCH 

01 The Act gave the Commission jurisdiction over all biomedical 
and behavioral research. The Commission is responsible for 
defining what constitutes biomedical and behavioral research 
and therefore what falls within its purview under the Act; 
any research involving people as subjects was do designated, 
as was any biomedical and behavioral research that techni- 
cally could be done on people (but is not done for ethical 
or other reasons, such as research using animal models), and 
any biomedical and behavioral research that has implications 
for individuals or for society. 

02 The Commission sets policies, guidelines, and regulations, 

with respect to: the protection of human subjects of re- 

search; the evaluation of risks and benefits to subjects and 
to society of research, including technologies that could 
reasonably be expected to emerge from the results of the re- 
search; and establishes specific precautions for conducting 
research. 

03 The most important distinction made by the Commission is to 
divide research projects into those that must be reviewed 
prior to implementation and those that need not be reviewed. 
Certain policies, established by the Commission, must be 
followed about research which does not require review prior 
to implementation. The Commission established a system of 
International Review Boards (IRRs) and Regional Review Boards 
(RRBs) to review all other research proposals. 

04 The responsibility for interpreting Commission policy about 
which research proposals must be reviewed rests with the 
prospective researcher. However, a researcher is able to 
obtain a ruling from either an IRB or RRB as to whether or 
not his/her project must be reviewed prior to implementation. 

05 Organizations that conduct biomedical and behavioral research 
can either establish their own institutional review boards 
(IRB) to evaluate each protocol and RIS, or rely on a Regional 
Review Board (RRB) for this purpose. All scientists and re- 
searchers not employed by an organization must apply to the 
RRB for approval of research proposals. 

06 Institutional Review Boards (IRBs). Each IRB must comprise 

Seven persons: Three scientists or researchers; three non- 

scientists or non-researchers from outside the organization 
(such as lawyers, ethicists, and representatives of the pub- 
lic), and a chairperson who must not be a scientist or re- 
searcher, or in the employ of the organization. All members 
are recruited and serve their terms according to procedures 
determined by the organization. A resume, Statement of 
Qualifications, and Conflict of Interest Statement for all 
IRB members must be filed with the local RRB and with the 


291 


Commission, and be available for public inspection. Detailed 
minutes must be maintained, including records of votes and 
Statements of dissent. An annual report of IRB activities 
must be filed with the RRB. The IRB is responsible for see- 
ing that researchers actually carry out work as stated in 
their proposal (the protocol and Research Impact Statement) 
through a system established by the IRB. Due process safe- 
guards such as hearings and appeals to the RRB (and finally 
to the Commission) are provided for the protection of re- 
searchers. The cost of operating the IRB is borne entirely 
by the organization. 

07 Regional Review Board (RRB) . There are ten RRBs, one for 
each DHEW Region. All RRB members are full-time employees 
paid from the same appropriations that meet the cost of the 
Commission. Each RRB comprises nine members: four scient- 

ists and researchers, four nonscientists and researchers, 
and a chairperson who is also a nonscientist-nonresearcher. 
Each board member serves a three year term; memberships are 
staggered to ensure continuity. While board members can 
serve more than one term, they cannot serve two consecutively. 
Nominations to RRBs may come from professional societies, 
citizens and other groups and from self-nomination. A re- 
sume, Statement of Qualifications, and Statement of Conflict 
of Interest must accompany each nomination. These documents 
are available for public scrutiny and comment. All selections 
are made by a majority vote of the Commission, after the pub- 
lic has had the opportunity to offer testimony on nominees 
or applicants. 

OS Researchers wanting to conduct a biomedical or behavioral 
reseacher project that requires review must submit a re- 
search proposal (application) to an IRB or to a RRB for 
approval, prior to commencing work. The proposal must con- 
sist of a protocol (outlining the experimental design, analy- 
tic methods, etc.), and a Research Impact Statement (RIS) . 

The latter must include a discussion in lay terms of: the 

purpose of the research; a summary of the methodology; a 
discussion of the use of human subjects if any; and the risks 
and benefits involved both to the subjects, if any; and to 
society of the research and of any technologies that might 
emerge from the research. A research proposal (protocol and 
RIS) turned down by one IRB cannot be filed with another IRB 
or RRB, unless this fact is stated. Additionally, the IRB 
or RRB turning down the original application must be identi- 
fied as well as the reasons for refusal. Any amendments to 
the original proposal must be clearly indicated. 

09 Review of research proposals (protocol and RIS) prior to im- 
plementation applies equally to individuals, private for-pro- 
fit, private non-profit, and public organizations. 

10 The decision to fund a particular research project is made by 
the agency or organization granting the funds, using what- 


292 


ever criteria it considers appropriate. However, agencies 
or organizations (public or private) granting funds must 
draw the attention of grantees to IRB/RRB approval require- 
ments. Although a researcher may secure funding for a re- 
search project, he or she cannot commence operations without 
approval by an IKB or a RRB. (The fact that a proposal is 
approved by an IRB does not mean anyone will fund it, however.) 

11 The IRB or RRB, as appropriate, must review each research 
proposal received to see that it meets all guidelines set 
for such research by the National Commission. The IRB or 
RRB can approve the research, call for modifications in 
methods, or prohibit it. On approval the research can begin. 

A copy of the RIS for each approved project must be filed 
with, the appropriate RRB and with the Commission withing 

30 days of commencement of the work. 

12 While the Commission does not approve research projects (RISs) 

prior to work commencing, it has the authority to halt re- 
search if any violations of guidelines are found in a RIS or 
if, in the opinion of Commission staff, serious risks to any 
individual or to society may result from the research. In 
the event that a project is halted, a hearing is held by the 
Commission. After receiving testimony from the researcher 
and other interested parties, the Commission can: allow the 

work to proceed as planned, or with modification; allow the 
work to proceed for a limited period with subsequent review 
for final determination; or prohibit the research. 

13 A researcher or a scientist who feels his research proposal 
was unfairly disapproved (by an IRB or RRB) may appeal to 
the Commission. Similarly, an IRB or a RRB member who felt 
a project was wrongfully approved could ask the Commission 
to halt it. However, only cases judged to have significant 
merit by the appropriate Commission panel (e.g., those that 
would be precedent setting or would require interpretation 
of guidelines) are actually considered by the Commission for 
resolution. 

14 Apart from reviewing research proposals (protocols and RISs) 
the RRB is responsible for monitoring the work of the IRBs 
within its jurisdiction to see that they adhere to Commission 
guidelines, and that they employ appropriate procedures to 
monitor the work of researchers within their organization. 
Monitoring takes the form of reviewing the minutes of IRB 
meetings, talking with IRB members, individual researchers, 
subjects, or interested citizens, as appropriate. A RRB ( may 
caution an IRB found to be deficient and review it again .in 
six months, disband it for a specified period, or abolish it 
entirely, as appropriate. In addition, the organization or 
an individual member of the IRB may be prosecuted if con- 
sidered to be negligent in carrying out IRB functions. These 
sanctions and penalties may be appealed to the Commission. 


293 


Each year the RRB must submit a report on the status and 
activities of IRBs within its region to the Commission. This 
report is available to the public. 

15 Each year. Commission Staff review a random sample of RISs 
to determine research directions, steps being taken to pro- 
tect human subjects, and evaluations of risks and benefits 
to both individuals and to society. A report of findings 
is published annually by the Commission. In addition, all 
RISs are available for public inspections at the offices of 
the Commission and RRB. 

16 The federal government operates a fund to compensate research 
subjects for harms suffered as a result of participating in 
research. The fund is supported from general tax revenues, 
and is administered by the Secretary of DHEW, although guide- 
lines for compensation are laid down by the Commission. 

Claims must be filed with the Secretary of DHEW, who after 
investigating the case, is responsible for determining, 
according to the Commission's guidelines, if a claimant is 

to be paid and the amount. The amount of compensation must 
be repaid to the bund by the organization (or individual) 
conducting the research if the Secretary's investigation 
finds they were negligent or otherwide did not observe 
Commission guidelines. In such cases, the Secretary may al- 
so rule that the organization (or individual) be prohibited 
from receiving public funds for a specified period. A 
person denied compensation, or an organization held negligent, 
may appeal the case to the Commission. While DHEW is respon- 
sible for processing claims and making compensation, all 
cases in which compensation was paid are reviewed each year 
by Commission staff and a report published documenting 
awards made, liability, and other pertinent findings. These 
reports are also used to revise or strengthen Commission re- 
search policies, guidelines, and regulations. 


294 


POLICY SCENARIO NO 4: IMPLEMENTATION OF BIOMEDICAL AND BEHAVIORAL TECHNOLOGIES 

01 The Act gave the Commission jurisdiction over the imple- 
mentation of all biomedical and behavioral technologies, 
both those existing at. the time it was set-up and those 
those that might be developed subsequently. Initially, 
the Commission concentrated on policies for new technol- 
ogies, later turning its attention to policies for tech- 
nologies being developed or tested or in use at the time 
it first became operative. 

02 The Commission is responsible for defining what constitutes 
a biomedical or behavioral technology and, therefore, what 
falls within its purview under the Act. Anything designed 
to test, monitor, improve, maintain, or treat human biomedi- 
cal or behavioral functioning was determined to be a bio- 
medical or behavioral technology. The Commission adopted 
the following classification of technologies: 

* Tangible technologies: All technologies which con- 

sist of a recognizable product. This would include 
all drugs, devices, or instruments, and equipment 
or facilities such as ambulances or coronary care 
units . 

* Intangible technologies: All technologies that de- 

pend upon information or services. These are 
further classed into provider-activated and self- 
activated categories. 

— Provider-activated: Those intangible tech- 

nologies that involve the services of a provider 
such as psychiatrists, surgeons or counselors. 
These are further classed as specific or non- 
specific. 

- Specific: surgical procedures, treatment 

regimens, etc. 

- Nonspecific: counselling, etc. 

— Self-activated: Those intangible technologies 

which do not require the services of a provider 
such as books on child rearing, transcendental 
meditation, diet, exercise, etc. 

The Commission determined that all biomedical and behavioral 
technologies except those that are intangible self-activated 
are subject to specific policies. 

03 A technology is first classified according to the stage of its 
development: application (first, limited use); and use in 

general practice (routine, more wide-spread use). Next it is 
classified according to its safety and efficacy to the indi- 
vidual and its risks and benefits to society. Separate 


295 


policies pertain to each stage of development, and to each 
safety-efficacy/ risk-benefit classification. 

04 The Commission sets policy with respect to the application 
of a technology, its use in general practice, and the 
assessment of a technology to determine if application 

or use in practice should be permitted and under what 
circumstances. Policies that pertain to application 
(given application is authorized) are directed toward: who 

may receive the technology and who determines if particular 
patients meet the specified criteria; what patients must be 
told about the technology; who may provide it; under what 
conditions; etc. Policies that pertain to use in practice 
(given use is authorized) include: identification of who 

may use the technology (e.g. if it can be sold over the 
counter, only prescribed by doctors, etc.); what information 
must be given to prospective users; etc. Policies that 
pertain to assessments include identifying those authorized 
to conduct them, how they are to be done, what data are to 
be collected, etc. 

05 While the Commission formulates policies with respect to 
what is to be assessed, how it is to be assessed, etc., the 
assessments of technologies are conducted by appropriate 
agencies in DHEW, such as FDA. The Commission evaluates the 
assessments made by the responsible agencies through the 
reports they issue. In addition, the Commission audits a 
random sample of assessments each year to ensure that they 
are carried out adequately and properly. A report of the 
functioning of the agency is then prepared and made public. 
Bureaucrats found to be deficient in properly carrying out 
their duties in accordance with Commission policies may be 
censured, dismissed, or the case referred to the Justice 
Department for prosecution, depending on the nature of 

the irregularities discovered. Bureaucrats may appeal any 
such action to the Civil Service Commission, except an 
indictment which is, of course, disposed of by the courts. 

06 All new tangible technologies, including drugs, etc. must 
be assessed prior to application (i.e. first, limited use) 
and again prior to use in practice. The purpose of these 
assessments is to determine the safety and efficacy of 
technologies for individuals and their impact on society. 

07 Assessments must be made by an organization or agency other 
than those that developed the technology. Moreover, persons 
who worked in its development cannot be employed to assess 
the technology (even if they now work for a different 
organization) . The cost of this independent assessment 

is borne by the organization that wants to market or use 
the technology. The organization that developed the tech- 
nology can perform its own assessment, however, results of 
the assessments are submitted to the federal agency monitoring 
the assessment. The supervising federal agency can order 


296 


a second independent assessment if the results of the first 
and those of the developing organizations differ markedly. 

The cost of this addit i.onal assessment is also borne by 
the organization that wants to market or use that technology. 

08 The results of the assessments are considered by the super- 
vising federal agency, which then designates whether or not 
the technology can be used, the conditions of use, etc., 

in accordance with the policies formulated by the Commission. 

An unfavorable ruling can be appealed to the National Commis- 
sion. The Commission, however, only reviews those cases 
judged to be precedent-setting, or those that would clarify 
or call for modification to existing policies. 

09 A new intangible, provider-activated, specific technology 
must be precisely described and the description filed with 
the federal agency designated by the Commission to supervise 
these technologies. Patients '(clients) may be offered this 
new technology, but the provider must inform them that the 
technology is experimental. The person or organization 
employing the technology must keep records in accordance 
with Commission guidelines and file annual status reports 

on the safety and efficacy of the procedure. 

10 Application may be made to the supervising federal agency 
to designate an intangible, specific, provider-activated 
technology as "accepted medical practice". The supervising 
agency can also initiate a review of the procedure, usually 
after sufficient time has elapsed for the data to be in, 

or if available evidence justified this. The evidence 
submitted in support of the application is then reviewed 
by an independent group of experts and the results of the 
review considered by the supervising agency. Responsibility 
for identifying experts rests with the federal agency, 
although an expert is randomly assigned to a particular 
case. The agency takes appropriate action in accordance 
with Commission guidelines. Such action may be to prohibit 
the procedure; to make persons inelibible to receive it if it 
is paid for by federal funds; to keep it as experimental 
technology; or to permit its use under specified circumstances. 
Rulings may be appealed to the National Commission, which 
usually only agrees to review precedent-setting cases. 

11 Under the Act, the Commission was mandated to evaluate the 
safety and efficacy of existing technologies that had not 
been evaluated to its satisfaction prior to use. First, the 
Commission undertook a review of the numbers of persons 
affected (i.e. using a technology each year) and the total 
annual cost of its use. Specific data were also assembled 
about the safety and efficacy of those technologies affecting 
the most people and those that were most costly. This 
latter task was assigned to the appropriate DREW agency, 
which also had to report on each of the technologies assessed. 
After review of the agency report, the Commission issued 


297 


its own report and recommendations for comment. Interest 
groups or individuals were then able to offer additional 
evidence or otherwise comment on the report. After the 
prescribed period, the Commission issued a final report and 
statement of policy. 

12 The Commission also established policies for monitoring the 
safety, efficacy, and impacts of technologies approved for 
use in practice. As new information becomes available, 
restrictions imposed by the federal supervisory agency may 
be lessened or tightened, as appropriate. Technologies may 
even be redisgnated as experimental or their use prohibited 
if new evidence warrants this. Again, the marketer or 
user of the technology may appeal to the National Commis- 
sion, although the Commission only agrees to hear precedent- 
setting cases. 

13 Failure by researchers, practitioners, marketers, or other 

users of technologies to observe Commission policies and 
guidelines may result in: an adverse report to the appro- 

priate professional regulatory board or society; loss of 
grants or contracts; prohibition from obtaining grants or 
contracts for a specified period; or loss of accreditation 
(e.g. a practitioner cannot treat patients whose care is 
paid for in whole or in part from federal funds). If 
failure to observe guidelines appears willful or to involve 
criminal negligence the case can be referred to the Justice 
Department for prosecution. This may result in fines or 
even a jail term, as specified in the Act. 

14 Insofar as intangible, provider-activated, nonspecific 
technologies are concerned, the Commission can require pro- 
viders to be licensed or registered, undergo special training 
or be accredited, or to provide specific information to the 
public, such as "the patients receiving the services I offer 
for your condition report no greater improvement than those 
not receiving such services." Responsibility for implemen- 
ting these policies is vested in the appropriate federal 
agencies . 




APPENDIX B 


SCHOLARLY ADJUNCT 


Report to: 


The National Corranission for 
the Protection of Human Subjects of 
Biomedical and Behavioral Research 


December 1976 





1 


The National Research Act (P.L. 93-348) which established the National 
Commission for the Protection of Human Subjects instructed the Commission, 
among other things, to undertake a "special study" of the implications for 
public policy of advances in biomedical and behavioral research and techno- 
logy. This mandate was described in section 203 of the Act in the following 
terms: 


The Commission shall undertake a comprehensive study of the 
ethical, social, and legal implications of advances in bio- 
medical and behavioral research and technology. Such * 
study shall include - 

(1) An analysis and evaluation of scientific and techno- 
logical advances in past, present and projected bio- 
medical and behavioral research and services; 

(2) An analysis and evaluation of the implications of 
such advances, both for individuals and society; 

(3) An analysis and evaluation of laws and moral and 
ethical principles governing the use of technology 
in medical practice; 

(4) An analysis and evaluation of public understanding 
of and attitudes toward such implications and laws 
and principles; and 

(5) An analysis and evaluation of implications for 
public policy of such findings as are made by the 
Commission with respect to advances in biomedical 
and behavioral research and technology and public 
attitudes toward such advances. 


This section derived ultimately from a resolution (S J Res 71) introduced 
into the Senate on March 6, 1973, by Senator Walter Mondale, which called for 
the establishment of a National Advisory Commission on Health Science and 
Society. In the course of the hearings which led up to the passage of P.L. 93 
348, the Senate Committee on Labor and Public Welfare made the following state 
ment with respect to the mandate: 

The Committee is impressed with the vast explosion of 
knowledge and progress in the field of biomedical and 
behavioral research and technology. The Committee 


1 1 


believes that these advances have far outstripped man's 
capacity to understand them and to maximally benefit 
from them . . . many of these advances will have the 
potential to alter the nature of our society. These 
changes in society are brought about in an orderly and 
constructive manner. Therefore, the Committee believes 
that the National Commission should undertake a compre- 
hensive investigation and study of these matters and 
should therefore incorporate the provisions of S J Res 
71 in this title. 


In addressing itself to section 203, the Commission issued a Request 
for Proposals to organizations interested in conducting this "special study" 
on behalf of the Commission. A Technical Review Committee evaluated a num- 
ber of proposals, and selected one employing the Delphi methodology with a 
panel of 125 persons. However, the Review Committee suggested that this 
study should be supplemented in two ways: (1) by a public opinion poll, 
and (2) by developing some way of drawing on the experience of a more limited 
number of leading scholars and scientists to focus on the issues raised in 
the special study mandate. This latter task was referred to as the "scholarly 
adjunct" to the special study. 

The present report is the outcome of that second phase of the special 
-study operation. It has been prepared by a "core group" of 6 scientists and 
scholars from Harvard University and Boston University, in collaboration 
with the staff of the Commission; and it incorporates the results of a larger 
discussion meeting with some 25 participants, held at Bishops Lodge, Santa Fe, 
New Mexico, in late June of 1976. 

At the Santa Fe colloquium, members of the "core group" took the chair 
at meetings of four working groups which concentrated on different sections 


1 1 1 


of the special study mandate, and in the preparation of this report they 
have accepted primary responsibility for corresponding sections of the 
document. Other participants in the Santa Fe meeting have also made sub- 
stantial contributions to the report: notably, to the three case studies 

included here as appendices. 

Given the broad scope of this report, it was not to be expected that 
all 25 participants should have viewed the problems of health science and 
health care in terms of the same priorities. Still, there was broad agree- 
ment over the manner in which we have characterized the interrelations be- 
tween biomedical and behavioral science and technology and the wider social 
context, and over the general policy goals that are enumerated in the final 
chapter of the report. As to the detailed ways in which those goals may 
best be achieved in practice, there were -- and remain -- a variety of opin- 
ions, depending both on the relative priorities one attaches to the different 
public interests involved, and on legitimate differences of judgment about the 
likely effects of alternative possible changes in the institutions and proce- 
dures of government heal th, science and health care delivery. 

As an advisory group, we have limited our own analysis and evaluation 
to the diagnosis of current problems, and the description of various policy 
options and goals. We have not felt that it was our proper task to choose 
between these options, or between alternative routes to the goals. The Com- 
mission itself will, presumably, be having to arrive at more formal "recom- 
mendations" to the Congress in the course of its own deliberations on the 
entire special study. 


IV 


Participants: Special Study Scholarly Adjunct 


H. David Banta, M.D. 

Office of Technology Assessment 
United States Congress 

Joseph V. Brady, Ph.D. 

Professor of Behavioral Biology 
School of Medicine 
Johns Hopkins University 

Richard J. Carlson, J.D. 

Senior Associate 

The Institute of Medicine 

National Academy of Sciences 

Eric Cassell , M.D. 

Cornell University Medical School 

Mr. Joe Coates 

Office of Technology Assessment 
United States Congress 

Harold Edgar, J.D. 

School of Law 
Columbia University 

Reverend John Fletcher 

Intermet Theological Seminary 
Washington, D.C. 

Jack Geiger, M.D. 

Department of Community Medicine 
State University of New York 
Stony Brook 

Clifford Grobstein, M.D. 

School of Medicine 

University of California, San Diego 

*Diana Hal 1 , Ph.D. 

Department of Biology 
Boston University 

John Hatch, Ph.D. 

School of Public Health 
University of North Carolina 

Halsted R. Holman, M.D. 

School of Medicine 
Stanford University 


*Gerald L. Klerman, M.D. 

Professor of Psychiatry 
Harvard University Medical School 

Perry London, Ph.D. 

°rofessor of Psychology 
and Psychiatry 

University of Southern Calfiornia 

Charles R. McCarthy, Ph.D. 

Division of Legislative Analysis 
National Institutes of Health 

*Everett Mendelsohn, Ph.D. 

Department of the History of Scier 
Harvard University 

David F. Musto, M.D. 

Associate Professor of Psychiatry 
(Child Health Center) 

Yale University 

*Barbara Rosenkrantz, Ph.D. 

Department of the History of Scier 
Harvard University 

Michael Shapiro, J.D. 

Professor of Law 

University of Southern California 
Law Center 

Roberta Simmons, Ph.D. 

Department of Sociology 
University of Minnesota 

*James Sorenson, Ph.D. 

Department of Socio-Medical Sc i enc 
Boston University Medical Center 

*Judith Swazey, Ph.D. 

Department of Socio-Medical Sc i enc 
Boston University Medical Center 

Gordon Tulloch, J.D. 

Department of Economics 
Virginia Polytechnic Institute 

William Wardell, M.D., Ph.D. 

Center for Drug Development 
University of Rochester 


* Core Group Members 


V 


CONTENTS 

Chapter 1: The Social Context of Policy for 

Biobehavioral Technology and Research 1 

Chapter 2: Biobehavioral Research and its Social 

Appl ications 31 

Chapter 3: Public Interest and Attitudes 47 

Chapter 4: The Ethical and Legal Channeling of 

Biobehavioral Technology 67 

Chapter 5: Public Policies and Policy Mechanisms 85 

Appendices: (i) Hypertension as a Problem in Preventive 

Medicine 115 

(ii) Mental Health and Behavioral Control 123 

(iii) Recombinant DNA -- Science as a 

Social Problem 151 














Chapter 1 


The Social Context of Policy for Biobehavioral Technology and Research 

1.1: The General Background to the Issues . The ethical, social, and 

legal implications of recent and prospective advances in biomedical and be- 
havioral research and technology, with which the mandate of this special 
study is concerned, need to be analysed and evaluated in their proper social 
and historical context. Biomedical and behavioral research or technology — 
"biobehavioral technology" for short -- enters into the pattern of human life 
within the industrialized societies of the late 20th century in complex and 
pervasive ways. On, the one hand, it is a significant agent of social change: 
so, many recent public discussions have emphasized the active roles of science 
and technology, as affecting the length, nature and quality of human life, 
both on the individual and on the social level. On the other hand, biomedical 
and behavioral scientists and technologists are themselves continually reactin' 
to changes in other features of modern society: in this respect, innovations 

in biobehavioral technology represent responses to other, larger scale changes 
in the patterns of social policy, individual behavior, and ethical belief. 

The two-way character of this interaction is often overlooked. For 
instance, the report of the Senate Committee on Labor and Public Welfare, 
quoted in our Preface, expresses anxiety that current advances in biomedical 
and behavioral research and technology may be "outstripping man's capacity 
to understand them," and "having the potential to alter the nature of our 
society." But the problems and processes in which biobehavioral technology 
is involved are more complex than this view suggests. The effects of Science 
on Society -- e.g., the influences which move from biomedical or behavioral 


science and technology toward the larger society — are inextricably bound 


2 


up with the effects of Society on Science -- e.g., those other, equally signi- 
ficant influences which move from the broader contemporary human situation 
toward the innovative activities of biomedical or behavioral research and 
technological development. Furthermore, both of these contrary sets of inter- 
actions need to be analysed and evaluated within a larger frame: notably, 

as they relate to the overall sequence of contemporary historical and social 
changes, many of which have nothing directly to do with health, or with the 
activities of health professionals. 

In its essentials, the character of life in the liberal democracies of 
the Western world during the late 20th century has been shaped by two funda- 
mentally non-technological factors: the experience of large-scale industriali- 

zation beginning around A.D. 1800, and the urbanization which followed upon 
it in Western Europe and Northern America. That dual process of industriali- 
zation and urbanization was, no doubt, the occasion for a striking wave of 
technological innovation; but it would be a grave oversimplification to assume 
that the resulting technological advances had themselves been the primary 
historical cause of the Industrial Revolutions with which they were associated. 
If anything, the reverse is the case. The beginnings of this industrial reor- 
ganization long preceded the technological innovations which it eventually 
exploited. Beginning with modifications in the medieval system of land- 
holding and agriculture in Western Europe, a succession of profound social, 
economic and organizational changes was necessary before it would become 
practicable -- during the years around 1800 -- to support, encourage, and 
take advantage of technological discoveries and inventions in the new "indus- 
trial arts"; and, apart from that social context, those innovations would have 
been without any major effect on human welfare. 


3 


Considering the scope of recent improvements in individual and public 
health in the United States, we may thus be inclined to assume that the 
single most significant influence on the length and quality of human life 
during the last 150 years has been the development of scientific medicine, 
and to expect further, comparable improvements from the same source. Yet 
the actual facts reveal a more complex picture. The development of sulfona- 
mides and other antibiotics has certainly given us a remarkable new power to 
control and cure many infectious diseases, especially the diseases of child- 
hood; yet, over thq last century and a half, the overall death rates after 
the age of 15 have changed to a surprisingly small extent. 

The real battle for health and against disease, indeed, has never been 
one for the medical profession alone. Even where adult death rates have 
changed substantially, it is not easy to disentangle the contributions of 
medicine and biomedical science from the consequences of other -- perhaps 
more basic -- changes in social structure, administrative procedure and human 
attitudes. Taking all things together, it seems likely that changes in housing 
codes, standards of employment and occupational safety, as well as in public 
attitudes toward sanitation, water purity and pollution, work practices and 
racial discrimination, diet and exercise -- which have taken place indepen- 
dently of, and alongside, recent changes in medicine itself -- have had more 
effect on many aspects of human health than the better practice of professional 
medicine. The contributions of the medical profession to the overall state 
of the nation's health are important, in some cases even crucial; so that 
problems in the economics of medical care, and in the provision of medical 
education, are legitimate matters of public concern. But, in the entire 


4 


pattern of health care and health policy, the role of the professional phy- 
sician -- especially, the professional physician in private practice -- is 
a limited one. In the overall improvement of the nation's health, the work 
of medical professionals and their scientific colleagues thus forms only one 
component within a much larger network of social and professional activities. 

These same more basic changes in social structure and public attitudes 
are relevant also to the "frame" within which priorities for medical research 
are determined, and the resulting biobehavioral technologies applied. On the 
one hand, the recent successes of scientific medicine have helped to forge 
a powerful new alliance between biomedical scientists and professional physi- 
cians. In turn, the strength of this alliance has tended to impose on policy 
makers and the wider public one particular, somewhat narrow definition of the 
"problems" of biobehavioral science and technology: a definition that focusses 

on the scientific study of somatic processes, and aims at the development of 
"technological fixes" for all health problems -- so distracting attention from 
the social determinants of the issues involved. (As we shall see later, the 
attractionsof this limited definition for research scientists and practicing 
physicians, respectively, are connected but not identical.) On the other hand, 
where innovations in biomedical or behavioral technology have been developed 
without regard to specific social needs or demands, and have been then intro- 
duced into society "out of the blue," their broader effects have been cor- 
respondingly limited. The consequences of such innovations have been most 
far-reaching, in cases where the innovations were themselves developed as 
responses to preexi sti ng social demands or needs. 


5 


It is instructive, for instance, to see how the 20th century develop- 
ment of new birth control techniques was related, in point of history, to 
contemporaneous changes in public attitudes toward sex and reproduction, 
family life and the ethics of pleasure. In this case, too, it is often sup- 
posed that a technological innovation was the primary cause , the social 
change the effect : viz. that the invention of the contraceptive "pill" has 
been the prime agency initiating an epidemic of sexual "permissiveness." 

Yet, once again, there is at least as strong an argument for seeing the 
actual causal relationship as going in the opposite direction. Considering 
the timing of the relevant changes in contraceptive techniques and in public 
attitudes, we may well conclude that it became practicable to develop and 
market oral contraceptives on a large scale in the years following World War 
II, only as a result of previous widespread changes in public attitudes 
toward sexual morality. Historically speaking, some workable methods of birth 
control have been known at more times, and in more cultures, than is generally 
assumed. If these techniques are "in demand" in industrialized countries at 
the present time, that is not because they are the products of brand new 
technologies: rather, it is because novel social factors -- e.g., the availa- 

bility of social security for the aged, and the threat of over population -- 
have undermined older arguments against limiting family size and encouraged 
a general reappraisal of traditional attitudes toward sexuality. In this case 
as in many others (it seems) we are too easily tempted to view technology as 
the primary cause of changes on the individual and social human levels; even 
where the basic direction of influence has been, rather, the reverse. 

Throughout this report, accordingly, we shall be discussing the implica- 
tions of advances in biomedical and behavioral research and technology for 


6 


ethics and society, law and public policy, as elements in a two-way interaction 
alongside, and in conjunction with, the implications of changes in the ethical 
and social, legal and political areas for the activities of biobehavioral scien 
tists and technologists themselves. Only in this way can one form a clear pic- 
ture of current problems, or recognize in what ways the current institutions of 
health science and health care are ill -adapted to tackle those problems. 

Certainly, the roles of "biomedical and behavioral research and services" 
in social and individual life have become increasingly complex and hard to 
grasp in recent decades; while, at the same time, the problems of public policy 
arising from the social involvement of biobehavioral technology have seemingly 
become more intractable. In our view, however, the reasons for this intracta- 
bility do not lie solely -- or even very substantially -- in the sophistication 
of the technological innovations themselves. First and foremost, they spring 
from the fact that biomedical and behavioral research and services nowadays 
touch on, and interact with, the broader patterns of individual, social and 
political life at so many more points, and in so many more ways than before. 
And, given the democratic traditions of American life, one inevitable conse- 
quence of this increasing scope has been a greater expectation by the public 
at large that they will have a chance to participate in critical decisions 
about the uses to which new biobehavioral technologies are to be put. 

Instead of narrowing our attention on to the detailed content of parti- 
cular socially influential innovations in biobehavioral technology, therefore, 
we shall attempt in this present report to focus: 

(1) on the processes by which biomedical and behavioral 

research and technology interact with the larger patterns 
of social and individual life; 


7 


(2) more particularly, on the decision points at which it 
is possible, practicable and useful to intervene in 
those processes, so as to channel them in desired 
directions; 

(3) specifically, on the various mechanisms -- ethical and 
judicial, administrative and political -- by which such 
channeling can best be offered. 

The resulting discussion will certainly not be narrowly "factual" or "value 
free"; nor could it* have been, given the Congressional mandate to "analyse 
and evaluate " the policy implications of biobehavioral technology. But we 
have done our best to state our ethical and social values and preferences 
explicitly; and we have deliberately rested the argument on social values 
forwhich there is broad acceptance in principle, even though their political 
consequences are not always recognized in practice. 

At first sight, the crucial policy problem in the biobehavioral field 
might seem to be that of bringing the Juggernaut of Technology under responsi- 
ble public control. Instead, the most fundamental and taxing problem turns 
out to be the preliminary one: of mapping, in comprehensive and discriminating 

detail, the growing network of interrelations within which biobehavioral inno- 
vations reinforce and contribute to, modify and react to social changes and 
vice versa. This introductory chapter provides a first rough sketch-map of 
this network, which will be filled out in more detail later in the report. 

1.2: The Widening Scope of "Health" and "Health Services ." The last 75 

years have seen striking changes, both in the general conception of "health" 


8 


current among professionals and lay people alike, and in the resulting hopes 
and expectations for the provision of "health services." A century ago, it 
was still the general practice to regard good health as consisting in a sim- 
ple freedom from illnesses, which were seen as afflictions or visitations of 
body or spirit, to be endured with patience and treated with wise care. Since 
then, a very different conception of health has arisen to challenge that earlier 
one: this selfconsciously "positive" definition, as adopted by the World Health 

Organization, presents health as "a state of complete physical, mental, and 
social well-being, and not merely the absence of disease or infirmity," to be 
fostered and promoted by deliberate social policy and active professional inter- 
vention. This newer conception has (it is true) been widely criticized for its 
extraordinary breadth and vagueness; yet it captures a view that has become 
widely influential -- even if as an expression of aspirations rather than of 
actualities -- and the consequences are particularly evident in public expecta- 
tions about the promise and potentialities of health care. This can be recog- 
nized clearly enough, both in the scope alloted to somatic medicine at dif- 
ferent stages during the last 75 years, and in changing public attitudes and 
expectations toward the psychological problems of human individuals and groups. 

(A) The Changing Function of "Medicine . 11 At the beginning of the 20th 
century, most medical practice still consisted in the care and management of the 
sick, and the physician rarely found himself in a position to cure his patients' 
diseases. At that stage, accordingly, the prime function of medical practice 
was pastoral . Since then, the practice of medicine has expanded into three 
new areas, and each fresh enlargement of scope has given rise to fresh public 
attitudes and expectations, so calling for new decisions about social policy. 


9 


(1) The most striking change since the year 1900 has been the great increase 
in the range of conditions that can simply be "put right": partly, as a result 

of improvements in our physiological understanding, but largely through the 
development of "antibiotic" agents, beginning with the sulfanomides in the 
1 930 ‘ s . As a result, one prime function of medicine has become curative . This 
change has not only given new powers to much professional practice in medicine 
but, even more, has transformed lay attitudes toward the medical profession. 
(Instead of devoted attention, the public has come to expect "magic bullets" 
and "miracle cures", for all identifiable diseases.) Indeed, many of the poli- 
cies, practices and relationships to which we are most accustomed in the mid 
1970's became securely established only as a result of this change: notably, 

the current tendency of much medical practice and biomedical research to focus 
on somatic or physiological factors and processes, and to downplay the social 
and environmental conditions of "disease." 

(2) Meanwhile, the practical scope of medicine has expanded further, 
going far beyond the provision of after-the-event "cures." Through the develop- 
ment of more discriminating indicators and diagnostic techniques, it has become 
possible, much more often than before, to recognize far in advance when a parti- 
cular patient is susceptible to a particular disease, or liable to develop some 
pathological condition, and take measures to prevent that outcome. In a word, 
one essential function of current medicine is now preventive . Similarly, 
through new developments in public health and social medicine, it has become 
possible to cut off the spread of many illnesses before they affect individual 
patients: whether through programs of innoculations, or through improvements 

in water supply or sanitation, or through social policies of other kinds. 


10 


(3) At the present time, furthermore, the scope of medicine is enlarging 
in two other respects, and as a consequence medical practice is becoming also 
corrective and augmentive . On the one hand, it is becoming possible to remedy 
directly certain physiological "defects" or "malfunctions," which would other- 
wise be liable to cause sickness, pain or mental anguish. One representative 
example of this new trend, at a superficial level, is cosmetic surgery: at 

a more basic level, the biomedical goals of "genetic engineering" would be of 
the same kind. On the other hand, it is becoming possible, also, to enhance 
and improve the quality and level of normal functioning; and this kind of 
"augmentive" task will very likely play an increasing part in medical practice. 
Such enhancement of functioning is already familiar in the area of sex therapy, 
but other comparable techniques are certainly on their way. For instance, we 
may expect to see the development of pharmacological agents and other treatments 
capable of enhancing an individual's intellectual or physical performance. 

This expansion of scope, by which the scope of pastoral and curative 
medicine has widened, to embrace preventive, corrective and augmentive func- 
tions, brings with it corresponding changes in the social implications, costs 
and organization of medical practice. Physicians whose armamentarium of 
remedies was confined to those available in the 1890's evidently had far less 
power to affect our lives (whether individual or collective) than those who 
can now cure serious infections in a couple of days, correct an ugly nose, 
improve our intellectual performances, and/or iron out our matrimonial pro- 
blems. Even more: as the scope of medicine has widened, its practice has 

become more highly institutionalized. Instead of looking to an individual 
physician for pastoral care, the patient nowadays deals with a complex 


11 


institutional system, and this fact significantly affects both the attitudes 
of attending physicians to those in their care, and also the impact on indi- 
vidual patients of the health services so provided. To say this is not to 
imply that particular physicians have less personal concern for their patients 
than did their predecessors. It is merely to recognize that, as the medical 
profession has become aggregated and the delivery of health services has been 
organized into larger institutional units, different sets of interests have 
become activated from those that embodied in the traditional "doctor-patient 
relationship. " 

The loss of this old personal touch, together with the sense of control 
that it gave to the individual patient, is even more evident where health care 
is a matter for preventive public health measures on a collective basis, rather 
than for the delivery of after-the-event treatment to individuals. In the field 
of public health, individual citizens can achieve understanding and control over 
practices having a significant effect on their health and welfare (e.g., fluori- 
dation) only by participating in the formation and implementation of the cor- 
responding social and political policies. And what makes the task of developing 
an adequate public response to the resulting problems so very complex is -- quite 
simply -- the sheer multiplicity of functions undertaken by contemporary medicine, 
and the correspondingly wide range of relationships, both individual and institu- 
tional, through which medical practi tioners interact with the larger public. 

(B) The Development of Psychological Sciences . The changes taking place 
during the present century in attitudes and expectations about the treatment 
of mental, psychological or spiritual afflictions are equally striking, if not 


12 


entirely parallel. In somatic medicine, the function of pastoral care always 
lay with the physician: the newer responsibilities — curative, preventive, 

corrective and augmentive — have simply been added to that primary concern. By 
contrast, responsibility for pastoral care in psychological matters was, by long 
tradition, vested in quite a different profession: viz., the clergy. Until 

recently, it was the duty and prerogative of ministers, rather than of physi- 
cians or psychotherapists, to console the bereaved, to give meaning to tragedy, 
to provide counsel to the emotionally confused, principles for parents in the 
education of their .children, moral and sexual guidance to the community in 
general. If at the present time psychiatrists, psychotherapists and other "men- 
tal health" professionals play a large part in the provision of such counselling 
the reason does not lie in some drastic 20th century epidemic of "mental 
disease": rather, it results from a new differentiation and allocation of 

professional responsibilities that were previously combined and centralized 
in the churches. 

Over the last 100 years -- for good or ill -- the pastoral role of the 
clergy has thus been gradually diminishing. Many of its functions have been 
taken over by secular agencies and professions: e.g., by lay schoolteachers, 

clinical psychologists, and social workers. In certain fields, notably psy- 
chiatry and public education, professional bureaucratic institutions have even 
developed, which compare in their scale and complexity to the churches them- 
selves. In some other formerly clerical fields, this has not yet happened: in 

the delivery of social services, psychological counseling, aptitude testing and 
the like, people of many different kinds are involved, and the moves toward 
professional monopoly and public licensure have made far less progress. During 


13 


the last 10 or 20 years, however, the provision of "psychological health ser- 
vices" has at last begun to put into practical application discoveries and 
techniques originally developed within the behavioral sciences, in the same 
systematic way that 20th century medicine has done with discoveries in phy- 
siology, biochemistry and allied sciences. 

We may speak here of the "behavioral sciences" in a broad sense: including 

not just psychology, but also sociology, anthropology , economics, history and 
all those disciplines which seek to apply scientific principles to the under- 
standing of human behavior -- past, present and future. In some of these fields, 
research follows the general patterns of basic science, e.g., using experimental 
methods to study learning in animals. In others, the methods are those more 
typical of applied science, e.g., employing psychotherapeutic techniques to 
correct learning disabilities in children, or using anthropological understanding 
to assist culture change in subliterate societies. 

While the scientific standing of research in these behavioral fields has 
not been recognized for as long as it has in the biological and medical (to say 
nothing of the physical) sciences, philosophical speculation about "human nature" 
-- aimed at an understanding of behavior, as related to its social and historical 
context -- has been continuous since classical times. The modern movement, aimed 
at developing more strictly "scientific" analyses of human behavior, developed 
in Western Europe and the United States during the late 19th century; and the 
new methods were first applied to practical problems in the educational field, 
with the development of intelligence testing in France. The resultive testing 
methods -- which came to have a broad application to personnel selection arid 
other kinds of aptitude testing -- were based on elaborate and sophisticated 


14 


experimental studies of learning, both in animals and in humans, as well as 
on research in applied statistics. They first caught public attention during 
World War I, when they were extensively used in assigning military personnel 
to different tasks. Meanwhile, parallel development were taking place in the 
field of psychotherapy . The earlier forms of psychotherapy were concerned 
primarily with hysteria and certain neurological pathologies, and were developed 
in the United States, France and Austria around the turn of the century. They, 
too, achieved public prominence during the first World War, in treating the 
psychological consequences of brain injuries, battle fatigue and "shell shock." 
Thus, practical application and social utility provided, from the beginning, a 
significant locus for the development of the behavioral sciences. 

During the years since World War II, the behavioral sciences have ex- 
panded rapidly, and three trends are particularly worth noting. Firstly, 
the methods employed in these fields of studies are increasingly technical 
and precise. Basic research in the behavioral sciences makes increasing use 
of mathematical models and statistical methods; and a similar emphasis has 
extended into such practical applications as psychotherapy, with the develop- 
ment of behavior modification techniques, biofeedback, sexual therapies, and 
group techniques. Secondly, the distinction between the behavioral and bio- 
logical sciences is increasingly blurred. The techniques of biofeedback indi- 
cate how useful physiological methods can be in dealing with problems of learning 
and psychotherapy; and experience with psychoactive drugs has shown the value of 
handling significant emotional and psychological problems by drug treatment, or -■ 
more effectively -- by judiciously combining drug treatment and counseling. 

Thus, physiology has come to the aid of psychological medicine. Conversely, 


15 


the behavioral sciences have begun to add important new insights to somatic 
medicine. For instance, epidemiological research is teaching us how far any 
individual's mode of life and personality, patterns of exercise and ways of 
coping with stress can affect his liability to coronary artery disease and 
similar physiological malformations. In this way, applied psychology will put 
us in a position to develop preventive and corrective health measures for dealing 
with significant physiological pathologies. 

Finally, in the psychological as in the medical field, the provision of 
"health services" is increasingly concerned with enhancing personal life by aug- 
menting normal functions. As the techniques of social psychology, physiological 
psychology and psychotherapy expand into the areas of learning and group rela- 
tions, family dynamics, sexual functioning and child development, the pursuit 
of "health" is moving away from the narrower, traditional sense of "freedom 
from disease," and is approximating the promotion of "complete physical, mental, 
and social well-being," as covered in the newer WHO definition. So, the last 30 
years have at the same time seen the behavioral sciences becoming more "scien- 
tific," by adopting more precise and sophisticated techniques from psychophysiology 
and psychometrics, and also more "socially oriented" and "techno! ogical ," through 
finding practical application to problems of education and nutrition, public policy 
and personal satisfaction. 

These progressive expansions in our conception of "health," and in the 
public's expectations about the delivery of "health services," may be used in 
passing to throw light on one topical controversy about medicine and the medical 
profession. It is sometimes claimed today that the current professional proce- 


16 


dures of medicine are themselves "iatrogenic," or "disease producing" -- i.e., 
that the procedures, rather than the patient's actual "complaints," define and 
even generate the conditions with which the physician deals. At one level, the 
number of tonsilectomies and hysterectomies performed in any given county is 
determined (on this view) primarily by the number of surgeons who have to be 
kept busy, only secondarily by any clearly indicative symptoms of organic patho- 
logy. At another level, the widespread condition known as "hypertension" common 
gives rise to no specific complaints, and warrants "treatment" only if we accept 
one particular interpretation, about the likelihood of the affected individuals 
developing serious circulatory problems at a later stage. The conclusion which 
some critics draw from these and other examples is that the medical profession 
is incorrigibly committed to somatic or physiological conceptions of "disease" 
and "treatment"; and that the general public can hope to free itself from iatro- 
genic illnesses only by destroying all medical monopolies, deprofessional izing 
the provision of health service, and developing lay systems of "self treatment" 
and mutual aid. 

The standpoint adopted in this present report is a different one. A 
narrowly somatic or physiological conception of disease does, in our view, have 
real and serious defects. Yet we do not believe that these shortcomings are 
insuperable, or that current medical practice is irredeemably committed to any 
such view. Rather, all those concerned with the pursuit of health and the pro- 
visions of health care services -- whether as professionals, or as shapers of 
public policies, or as concerned members of the lay public -- need to understafl 
how the scope of the health sciences and biobehavioral technology have changed 
during the current century, and become more responsive to the social, h/d iviora 


17 


and ethical dimensions of the resulting problems. Heart disease may appear 
a purely somatic condition, in a way that (say) anxiety or industrial injuries 
are not. But our current understanding of the antecedents of even the most 
clearly somatic illnesses brings with it the plain lesson that no such sharp 
distinction can safely be drawn. Pathological conditions of all kinds have 
social or psychological, as well as organic or physiological determinants. In 
the long run, therefore, the most effective way to deal even with somatic pro- 
blems may well be to devise social or behavioral, rather than purely somatic 
solutions. 

1.3; Health and Social Policy: The Blurring of Responsibilities . If the 

boundaries to such terms as "health" and "medicine" have changed so strikingly 
during the 20th century, so too -- in consequence -- have (1) the social locus 
of professional medicine and psychotherapy, (2) the ways in which biobehavioral 
research and practice pose social or political problems, and (3) the resulting 
needs to subject these enterprises, along with their attendent monetary and 
social costs, to public scrutiny and/or governmental intervention. More parti- 
cularly: it is increasingly difficult to draw any hard and fast lines between 

"medical" or "health" services, and human or social services of other kinds. As 
the goal of the health professions shifts away from managing diseases and post- 
poning death, toward improving the auality of human life and functioning — both 
individual and collective -- the practical decisions facing physicians and psycho- 
therapists are moving away from strictly "technical" matters, toward the patient's 
work habits and plan of life, his social relations and even his basic ethical 
attitudes. Correspondingly, the problems of "health" now facing governmental 
and other policy makers -- in the new WHO sense, of "health" as physical, mental. 


18 


and social well-being -- make it increasingly hard to mark "health problems" 
and "health services" off from other kinds of social problems and social ser- 
vices. 


Health problems, in consequence, nowadays overlap with problems of nutri- 
tion, and environmental protection, employment policy and education, social 
welfare and even recreation. (1) To begin with nutrition : at one extreme, 

there are still many Americans whose health is at risk from nutritional defi- 
ciencies -- including many young children, who can be permanently damaged by 
under-nutrition. Lacking coordinated policies for tackling the problems of 
health and nutrition together, physicians may find themselves unable to treat 
the resulting "ill health" in the only effective way. The one "medicine" truly 
specific for starvation -- viz., food -- is not a prescription drug, and the 
provision of food stamps is not administratively recognized as a "medical" matter. 
At the other extreme, many Americans are exposed to the diseases of over-nutri- 
tion and, with the shift of attention from infections to (e.g.) heart disease 
and stroke, the significance of dietary habits is becoming clearer every year. 

On the level of national politics, however, public policies toward eating, drinkir 
and other forms of "consumption" have, hitherto, been almost exclusively con- 
cerned with restrictions and prohibitions, designed to limit or control the use 
of alcohol and narcotics, or at best to banish the last marginally carcinogenic 
additive from commercial food products. The political imagination of the count.)')' 
has not yet been captured by the truly massive health problems generated by sheer 
excessive calorie intake, and by over-consumption of fats, refined sugars and 
cholesterol -- which result in far more disabling illness and premature death 
than are ever likely to be caused by commercial food coloring agents. 


19 


(2) Similar obstacles exist also where health policy runs up against 
policies for em ployment . There is growing evidence today that hypertension 
and similar states spring largely from unsatisfactory conditions of life, nota- 
bly from bad working conditions and similar forms of stress; yet professional 
physicians and policy makers alike still tend to assume that such circulatory 
conditions are best treated in pharmaceutical ways, even though an effective 
national program for tackling such conditions would have to attend also to the 
social practices involved. In this and other areas, issues of medical policy 
cannot be set apart from issues about employment standards and occupational 
safety, industrial organization and similar broad social issues. Indeed, the 
long term side effects of ignoring these social factors and continuing to 
medical lze" such problems -- that is, defining them in terms amenable to 

purely somatic therapy -- may in many cases be even worse than the original 
conditions themselves. 

(3) In the area of environmental protection likowisa- there are clear 

associations between current levels of air pollution and the widespread occurence 

of respiratory disease, in several parts of the U.S.A. the public water supply 

is also in an unsatisfactory condition, while the spread of carcinogens may 

evidently result as much from atmospheric pollution as from food coloring agents 

or the like. Yet long-established political and administrative habits still ham- 

i Per the dev elopment of effective policies for tackling problems of environmental 

health. The sheer political "clout" of the industries generating much of this 

air and water pollution has stood in the way of the reforms needed to prevent 

. 

U; and the political debates about ecology and environmental protection still 
too often treat the subject as concerned only with esthetics and amenities — 
the professor's petunias are wilting" -- while ignoring the grave and widespread 
public health problems arising from inadequate environmental control. 


20 


(4) Such overlaps between health problems and other social problems occur 
in the behavioral, quite as much as in the biomedical field. Public education 
and private psychotherapy (as we noted) are both specialized descendants of the 
general psychological services traditionally provided by the clergy; and their 
differentiation is still not yet complete. So, problems of definition and juris- 
diction still arise along the boundaries between health policy and education 
policy. Some psychologists would claim that the best school and college teaching 
has always relied on techniques of "behavior modification"; and argue that dis- 
coveries of contemporary psychology can contribute significantly to raising the 
standards of education, by making possible still more effective methods of in- 
struction. Yet any model of education as aimed at "psychic health" has only a 
restricted part to play in debates about educational methods and policies. The 
professedly "value free" character of psychological inquiries and techniques -- 
whether in intelligence testing, learning theory or behavior modification -- 
limits their value when it comes to dealing with the "value laden" problems of 
educational policy and administration; and the long history of institutional 
separation between medicine and education only accentuates these limitations 

in practice. As a result, though the problems of education and mental health 
are becoming increasingly close, important and difficult issues of social 
policy and public values will continue to arise at the boundary between them. 

(5) Similarly, with w elfare and social services : in the field of family 

welfare, for instance, better psychological understanding of normal child develop- 
ment, and its vicissitudes, have led to the development of "family therapies" 

and other procedures. These and similar innovations are helping to take much of 
psychiatric medicine out of the asylum or state hospital, and into new areas of 


21 


public service, which involve broadly social and ethical values as well as more 
strictly medical techniques. This "deinstitutionalization" of mental treatment, 
and the associated development of community mental health services has some un- 
doubted virtues; yet it is not clear that the resulting social and policy over- 
laps between health and general welfare services are truly understood. In other 
directions, too, the expansion of behavioral technology is inevitably leading 
many health professionals across the thin line separating matters of "health" 
from broader issues of "welfare." The physician who advises an obese client to 
change his diet and working habits rather than taking (say) hormone pills -- like 
the public health official who seeks to drum up support for improving his com- 
munity's water supply -- is thus inescapably led into moral counseling as well 
as orthodox medical therapy, political lobbying as well as administrative planning. 
Finally, with the spread of the health services into "augmentive" medicine and 
psychotherapy, physicians and psychotherapists are offering people the chance 
not merely to escape actual disease, but also to live fuller and richer lives; 
and this change is blurring not merely the distinction between health and edu- 
cation, but even that between health and recreation. (At what point do "occu- 
pational therapy" and "recuperation" blend over into "recreation," or "encounter 
groups" become a new kind of social club?) 

This progressive erosion of the lines that formerly separated health matters 
from other matters of social and political concern faces us with practical pro- 
blems, most particularly, because our institutions respond very slowly to such 
changes. So long as the main therapeutic tools of medical practice were certain 
straightforward prescription drugs and surgical procedures, one could delineate 
"medicine" from its neighbors rather sharply, and it was a comparatively simple 
matter, as a result, to administer a "medical" insurance scheme or insure the 


22 


safety of new "medical" agents. As the health field broadens, by contrast, 
we are compelled to pay more attention to social, environmental and similar 
issues; and existing patterns of policy making and administration place 
correspondingly more constraints upon us, thus exposing the overall public 
welfare to arbitrary bureaucratic distortions. 

Since the practical problems with which the average citizen needs pro- 
fessional help are less and less easily classified into neat categories -- 
legal as contrasted with medical, physiological as contrasted with psycho- 
logical, welfare problems as contrasted with spiritual problems -- existing 
institutions and practices are thus liable to become correspondingly obsoles- 
cent. Administrative structures or insurance schemes designed to tackle the 
problems of one decade place obstacles in the way of developing social ser- 
vices (including health services) matched to the actual needs of a later 
decade. As we shall see, therefore, some of the most urgent problems raised 
by innovations in "biobehavioral technology" are, precisely, those concerned 
with monitoring the functioning of our institutions and administrative struc- 
tures, so as to anticipate and guard against this kind of institutional obso- 
lescence. 

1.4: Perspectives on the Analysis of Health Policy . In considering 

the social context within which innovations in biobehavioral technology are 
developed and utilized, we have been led to pick out three connected sets of 
themes for special emphasis: 

(1) the two-way nature of the interaction by which technological 
changes (in medicine and psychotherapy , as elsewhere) influence, and are in 


23 


influenced by, changes in the broader social, economic and political situa- 
tion. 

(2) the one-sided ways in which the actual complex determinants 
of health (environmental, social and behavioral, as well as somatic) are 
currently reflected, alike in the accepted priorities for biobehavioral re- 
search, and in the general patterns and modes of medical and psychological 
treatment. 


(3) the .need to redefine the different responsibilities in the 
provision and utilization of health services -- firstly, between the medical 
and scientific communities, on the one hand, and individual patients on the 
other; secondly, between the government, on the one hand, and private indi- 
viduals or institutions on the other; and, finally, between all the different 
public agencies concerned with social problems and social services of one 
kind or another. 

These themes will be picked up again at the end of this report, when we turn 
to discuss the policy goals suggested by our analysis. 

In the chapters that follow, we shall deal in turn with three topics 
specifically raised in the Congressional mandate for this special study. 

Chapter 2 will consider the role of scientific research, particularly govern- 
ment sponsored research, as a factor in the generation of new biomedical and 
behavioral technology, with special reference to the broader context within 
which research is undertaken, and the special conditions required in order 
to provide for the fruitful pursuit of scientific discovery. Chapter 3 is con- 
cerned with public attitudes towards biobehavioral research and services, 


24 


notably with changes in the nature of public knowledge about, and concern with, 
biobehavioral science and technology. Chapter 4 describes the existing means 
available for the ethical and legal channeling of biobehavioral technology, 
and draws attention to some of the points at which the available mechanisms 
appear to fall short of current needs. Finally, in Chapter 5, we shall present 
a number of general policy goals, and indicate some of the options for moving 
toward these goals that were identified and discussed in the course of our 
discussions at Santa Fe and elsewhere. 

In addition, three case studies are included as appendices, at the end 
of the report. Their aim is to give some more "body" to our analyses and pro- 
posals, by illustrating how they apply to some representative examples in more 
detail. The first of these studies deals with the problem of "hypertension," 
as an issue in preventive medicine, having complex social, environmental and 
political, as well as technical implications. The second study surveys recent 
changes in the field of mental health, with particular reference to the use of 
psychoactive drugs and "behavior control" techniques. The last study reports 
on, and discusses, the political issues raised in the current controversy about 
"Recombinant DNA" research, as illustrating the new ways in which research scien 
tists are having to become "accountable" for the social implications and effects 
of their work. 

Let us touch briefly, here, on just a few of the issues that will be 
discussed at greater length below. (1) At the scientific end of the biobe- 
havioral spectrum, there is a significant lag in dealing with the problem of 
research priorities . Whereas the wider public is increasingly aware of the 
relevance to health of social and environmental factors, with all their 


25 


practical overtones and implications, the biomedical research community -- 
when left to run its own affairs -- is still inclined to overemphasize the 
somatic (or physiological) aspects of disease, which lend themselves better 
to straightforward, uncontroversial investigation within the monastic calm 
of the scientific laboratory. This divergence of interests is liable to 
enhance the strains currently affecting the "social contract" between the 
United States scientific community and the American public at large: the 

contract that has survived, at least, since the establishment of the National 
Science Foundation under the Truman administration, following the "concordat" 
outlined in Vannevar Bush's report. Science, The Endless Frontier . 

At the present time, some serious rethinking is called for, both about 
the need to protect and promote the vital interests of basic science itself -- 
for all those reasons which Vannevar Bush rightly underscored -- and about the 
need to enlarge the range of options taken into account in determining the 
priorities of applied research. As to that: biobehavioral scientists sometimes 

dismiss all suggestions that the lay public must play some part in this re- 
thinking, on the ground that non-scientists are unqualified to appreciate such 
inescapably technical issues . Yet it must be replied, with equal justice, that 
many professional scientists and physicians are also handicapped in such dis- 
cussions, since they do not always understand the public values and interests 
involved. Whatever may be the case within the field of pure science, accordingly, 
public priorities for applied research in our view require discussion by joint 
lay/professional groups; and active participation by lay representatives in 
this kind of decision making is, almost certainly, the best way of rebuilding 
an informed and sympathetic public constituency for biobehavioral research. 


26 


(2) Meanwhile, at the practical end of the spectrum, we shall be echoing 
the general concern with the problems of cost control, while noting that the 
pursuit of "technological fixes" for problems of a complex social character can 
often increase the apparent need for expenditure, without producing any com- 
mensurable results. (Having too much money or expensive apparatus can block 
effective problem solving, as surely as having too little: those who have to 

work with "sealing wax and string" are obliged to tackle their problems with 
more ingenuity and imagination than those who are enslaved to elaborate tech- 
nological machinery.) Nor is this simply a matter of the quantitative econo- 
mics of health care: the current emphasis on sophisticated technology has also 

affected the character of health care services in the United States, in quali- 
tative ways, not all of them desirable. 

For example: there has been a growing centralization of medical faci- 

lities in large capital intensive hospitals equiped with costly and wonderful 
apparatus, whose operations are nonetheless remote from the actual lives and 
problems of the people to whom they provide care. The technical arguments 
in favor of this centralization are clear enough; but the social arguments 
against this tendency also need be considered with equal seriousness. In the 
field of education, the principles of lay participation have never been aban- 
doned and the corresponding tendency toward centralization has been success- 
fully resisted -- particularly, in the area of primary education: in that field 

the price to be paid for centralization, in the way of depersonalization and the 
loss of democratic accountability, has been judged unacceptable. The field of 
biomedical and behavioral services is faced with essentially the same policy 
choices. If we chose to resist depersonalization and loss of democratic account 
bility, we could do so; just as those tendencies have been resisted in the pro- 


27 


vision of education. And the experience of other countries -- Israel, say, 
quite as much as China -- encourages a belief that community health centers 
and family planning services (like primary schools) could be made generally 
available if we pleased, if not on every block, at least within eal^wal king 
distance of every city home. 

If we are ever to reach that point, however, it will be necessary to 
set aside the current preoccupation with the technology of health care, and 
to recognize that technological issues are currently masking other, underlying 
social and economic issues. To provide general health care by setting up a 
network of neighborhood "health centers," for instance, would certainly have 
the effect of reducing, both the technological component in health care deli- 
very, and the scale of capital investment required in costly apparatus. Yet 
the improvement in the national health brought about by such a program would 
probably be greater than anything that could result from further massive invest- 
ment in technologically sophisticated equipment. Similarly, the diehard opposi- 
tion of the American medical profession to any general replacement of "fee" 
payment by a system of "salaried services" (such as has long been instituted 
in the field of education, and even in the armed forces' medical services) 
probably does more to drive up health costs than any technological innovations. 
At any rate, these social and economic choices need to be faced explicitly; and 
we need to recognize, in particular, that policy choices taken on this level are 
prior to -- and largely preempt -- all subsequent technical decisions about the 
utilization and control of innovations in biobehavioral technology. 

To sum up: the biomedical scientists and research psychologists, physi- 

cians and psychotherapists who create and utilize biobehavioral technology 


28 


carry on their professional work at the present time within a rapidly changing 
social context. During the last few years, the activities of biobehavioral 
science and technology, medicine and psychotherapy, have moved away in a dozen 
directions from a simple concern with "bodily defects," to embrace social, 
environmental and other "problems of living." This expansion in the scope of 
the health and health related professions is a primary fact underlying all sub- 
sequent, narrower questions about the implications of technology with the 
general health field;, and it has helped to set up a basic tension, which affects 
all decisions about policy for health and health services. 

On the one hand, there is a continued momentum toward "medical izing" all 
fresh types of problems ssstf as they emerge, even in fields not hitherto re- 
garded as the concern of the physicians or psychiatrists (including some that 
are fundamentally social, ethical or political rather than technical), and so 
to make over an even larger range of autonomy to the professional communities 
of science and medicine. On the other hand, there is a new but growing counter 
pressure toward "demedical izing" the health services, and reclaiming the lay 
public's right to a say in policy and administration throughout the health field, 
even in medicine itself. In the short term, of course, the former direction of 
development is the more "comfortable" one, since it allows us to leave the pre- 
sent institutional arrangements just as they are; and, not surprisingly, powerful 
voices have recently been raised in its support. Yet, in the longer run, there 
is reason to believe that continuing to move in this direction alone will only 
aggravate the risk of polarization between the lay public and the biomedical 
professions, through failing to provide proper representation for the public's 
legitimate interest in the ethical and social aspects of contemporary health 


29 


science and health care. Moving in the opposite direction, by contrast, will 
mean accepting the need for some structural changes in the institutions by 
which biobehavioral research is currently undertaken, and health services pro- 
vided, in the United States. Yet the question must be faced, whether it will 
be possible to deal effectively either with the political tensions between the 
biomedical professions and the public, or with the social and ethical problems 
raised by current biobehavioral technology, unless we are prepared to reana- 
lyse the place of those institutions within the larger community, and devise 
changes designed to adapt to the new situation. 

In the years ahead, this tension between "medical ization" and "demedi- 
calization" will remain a basic element in all policy discussions about health 
and health related issues. Our current problems cannot be dealt with in any 
simple minded way, by choosing to move comprehensively in one of the two 
directions, rather than the other. We live in a situation in which, at certain 
times and in certain respects, it will be necessary for us to move in either 
or both of these directions; and we must take all our resulting decisions in 
ways that acknowledge, and balance off, the legitimate claims of both the pro- 
fessions and the lay public. For the biomedical research community of course 
has its own proper concern, to ensure that the intellectual and practical con- 
ditions for fruitful scientific work are not disrupted by the reckless and 
uninformed criticism of politically motivated "outsiders." Yet science and 
medicine may expose themselves to even more serious dangers if their profes- 
sional communities adopt a purely defensive posture, and seek to preserve the 
existing institutional arrangements at all cost. 


30 


Throughout the present report, therefore, we have found it insufficient 
to consider "the ethical, legal, social and public policy implications" of 
contemporary biobehavioral science and technology with an eye to the pattern 
of institutions and administrative mechanisms currently in place: in addition, 

we have felt bound to ask ourselves also what alternative institutional arrange- 
ments are possible, and what new policy options would be created by adopting 
such alternative arrangements. Rather than confining ourselves to the content 
of possible policies for particular biobehavioral technologies, considered in 
isolation from their institutional context, we have accordingly interpreted 
the Congressional instruction to consider "policy implications" as including, 
also, implications for the institutional machinery through which policies for the 
health services and health service delivery are formed and implemented. 

One final caution needs to be added at this point. Just because we 
have chosen to analyse and evaluate the development and influence of biobe- 
havioral technology against a very broad social background, we have scarcely 
been able to suggest ways in which all the current difficulties in this area 
can be corrected by straightforward Congressional action. As will be apparent, 
indeed, many of these difficulties are simply particular aspects or consequences 
of certain much larger social processes, which are themselves too vast to be 
effectively controlled or directed by simple legislative or administrative measure 
The policy goals to which we direct attention in the final chapter of this report 
should accordingly be read, not as proposed "solutions" to specific "problems," 
but rather as possible ways of responding adaptively to -- and so lessening the 
severity of -- social conflicts and transitions that, in themselves, are pro- 
bably unavoidable. 


31 


Chapter 2 

B iobehavioral Research and Its Social Applications 

2.1: The Multiple Pathways of Research and I nnovation . Discussions 

about the implications of biobehavioral research* and about the policies 
that guide (or ought to guide) both the conduct of that research and the 
application of its results in health care, necessarily rest on assumptions 
about the nature of scientific innovation and its relations to the social 
context. For example: one particular view, which treats health care as 

"applied biomedical science" -- the view sometimes known as the Bench to 
Bedside view -- has played an influential part in the development of the 
existing institutions of health care and health research in the United States, 
and is presupposed in many current policy discussions about science, medicine 
and health care. (It can even be detected at work in Senator Mondale's Reso- 
lution, S.J. 71, from which the present "special study" takes its origin; 
since that resolution speaks throughout of the effects of biobehavioral 
technology on_ society, rather than of the responsiveness of that technology 
to society. ) 

Given their relevance to questions about policy for health care and 
biobehavioral technology, these assumptions need to be examined here with 
some care. In this chapter, accordingly, we shall explain our views on the 
nature and social context of biobehavioral research, indicating some of the 
ways in which such considerations bear on the decisions that affect the appli- 
cations of biobehavioral research and technology in health care. 

In criticizing many of the traditional views about the nature of re- 
search and how it impinges on society, we shall at the same time be arguing 


32 


that the scientific community has real and substantial needs. But our dis- 
cussion will also suggest that the reactions of many contemporary scientists 
against calls for public accountability and for greater public participa- 
tion in decisions about research policy, are based on oversimplified views -- 
not confined to scientists -- about the nature of the scientific enterprise 
itself. 

Scientific discovery and therapeutic innovation are, in fact, complex 
processes, and relatively little reliable knowledge exists about their course 
and determinants, particularly in the case of twentieth century developments. 
The importance of gaining a better understanding about the nature of research, 
including the ways in which "practical applications" may be generated, is 
underscored by current pressures on biomedical scientists and the government 
funding agencies to concentrate on "applied," "mission-oriented," "targeted," 
or "categorical" research: intended to find solutions to specific health care 

problems as rapidly as possible. For the past decade, as a result, debates 
about the relations between "basic" and "applied" research have been often 
strident though, as Alvin Weinberg pointed out in 1967, "The argument about 
the relationship between applied and basic research -- the confrontation of 
the Baconian and Newtonian views -- has been raging since the 1700's." And, 
Weinberg cautioned, 

because the question [about the basic-applied rela- 
tionship] is once more asked in sharp and urgent terms, 
particularly with respect to biomedical research, [that] 
by no means implies that new or particularly cogent in- 
sights have been attained. 

To begin with, then, we would argue that stereotyped accounts of how re- 
search is done, in terms of "the scientific method" -- as found in the intro- 


33 


ductory pages of scientific textbooks -- bear little resemblance to what 
researchers actually do in their laboratories or clinics. The received 
wisdom about science tells us that research, new knowledge, and its appli- 
cations progress incrementally, by adding each fresh "discovery," like a 
new "brick," to previously laid bricks in the slowly rising edifice of 
"truth." In traditional formulations, science is also held to be an autono- 
mous, "objective" endeavor, in which scientists eschew dogma, are value- 
free, and rely entirely on experimentation and hypothetico-deductive thought. 
Another more recent element in the received view of scientific research and 
discovery concerns the role of "serendipity." Because serendipity is misun- 
derstood as a kind of totally fortuitous, chance discovery, it has been ele- 
vated into a general explanation of the fact that basic research often 
yields unforeseeable new findings and applications. 


Views of science contravening this traditional image have long been 
proferred by philosophers, historians, and by some scientists themselves. 
In 1975, for example, Sir John Eccles, a Nobel Laureate neurophysiologist, 
wrote: 


I experienced a great liberation in escaping from 
the rigid conventions that are generally held with 
respect to scientific research. Until 1944 I held 
the following conventional ideas . . .: First, that 

hypotheses grow out of the careful and methodical 
collection of experimental data. . . . Second, that 
the excellence of a scientist can be judged by the 
reliability of his developed hypotheses. . . . Finally 
. . . that it is in the highest degree regrettable and 
a sign of failure if a scientist espouses an hypothe- 
sis that is falsified by new data so that it has to be 
scrapped altogether. When one is liberated from these 
restrictive dogmas, scientific investigation becomes 
an exciting adventure opening up new visions. 


34 


Traditional views about the "essential nature" of scientific research 
impinge upon real-life decisions about the management of research in a 
number of ways. It is often assumed, for example, that although Science 
makes valuable contributions to the public good through practical applica- 
tion, the actual processes and needs of the research itself are "craft mys- 
teries," which can be truly understood and estimated only by those actively 
involved in the research. The autonomy of Science is, as a result, not just 
an historical accident or operating strategy, but a precondition for serious 
research: any outside intervention in the real work of science by those not 

"in the know" can only have the effect of disrupting that work. A second 

assumption is that the requirements which scientists themselves perceive as 

necessary for their research have to be presented to prospective patrons -- 

including governmental agencies -- in the form of "non-negotiabl e demands." 
If the Federal Government decides to lend its financial support to Science, 
well and good; but, given the complex, selfdirected, and fragile nature of 
the scientific research enterprise, this support must be given (if at all) 
on Science's own terms. 

About these basic assumptions, two initial comments need to be made. 
First: so far as concerns of choice of specific topics in very basic areas 

of scientific research, they contain a real kernel of truth. The question, 
which of several alternative lines of investigation shows most promise of 
improving our fundamental ideas about some given aspect of Nature, can cer- 
tainly be approached only by people who are at home in the science concerned; 
and any temptation for governmental authorities to patronize one group of 
pure scientists rather than another, for reasons external to the needs of 


35 


the particular scientific discipline, should be resisted. (The Lysenko affair 
in Russian genetics illustrates the damage that flows from disregarding this 
maxim.) Secondly, however, any extension of this maxim to all the broader 
issues of "science policy" would be fallacious. The decision to give public 
financial support to scientific research at all is an essentially political 
decision; and decisions about what kinds of applied research to select for 
support involves not only technical considerations from within the discip- 
line, but also considerations of social policy and priorities. As such, 
policy needs to be determined in ways that allow for adequate public "input." 

Traditional accounts of the nature of research and innovation also tend 
to present a simplistic, unidimensional picture of how useful results, or 
applications, come about. In the biomedical or biobehavioral arena, this 
process is seen as progressing unilaterally "from the lab to the clinic" -- 
from unfettered basic science inquiries to an eventual useful application 
in the practice of medicine. 

To challenge this lab to clinic (or bench to bedside) view of biomedical 
research is not to play down the importance of "basic" research, both as an 
endeavor in its own right and as an essential element in the acquisition of 
new medical knowledge and technique. It is simply to recognize the fact that 
has begun to be well documented in recent sociological and historical studies; 
namely, that biomedical research involves complex, two-way interactions between 
"categorical" (disease-oriented) investigations and more "fundamental" (discip- 
line-oriented) research avenues, in addition to the critical social determi- 
nants already discussed in our first chapter. 


36 


To the extent that we acknowledge the complexity of biomedical research, 
we must correspondingly recognize that much of this work can be labeled as 
strictly "basic" (or "fundamental") on the one hand, or as "applied" or 
("categorical") on the other hand, only with difficulty. As such, the dif- 
ferent kinds of biomedical research fall along a continuing spectrum, directed 
toward the phenomena of health and illness. At one end of this spectrum, we 
are clearly in the area of "applied technology"; but, at the other end, it 
is hard to find any area of "basic" research so remote from practice that 
does not involve any prospective "practical use," at a sufficiently distant 
time. In most instances, characterizing research as "basic" or "applied" 
is further complicated by the need to specify whether this distinction is 
being applied to (1) the particular problem being investigated -- whether 
disciplinary or technical -- (2) the personal motivation of the researcher -- 
whether scientist or physician -- (3) the source of funding -- whether science- 
oriented or mission-oriented -- (4) the locus of the research activity -- uni- 
versity or hospital, say. Considering these four factors separately, we may 
be led to give very different characterizations to one and the same piece of 
research, which may qualify as "basic" by one standard, "applied" by another. 

In sum, the "basic"/"appl ied" distinction is often used in a super- 
ficial way; and the labelling of research activities as basic, fundamental, 
applied, categorical, etc , is largely a heuristic device, having little 
reference to the actual course and determinants of biobehavioral research 
and innovation. If we study the actual course of biomedical research pro- 
jects, we may be struck by these comments of Paul A. Weiss, whose own investi- 
gations into morphogenesis -- ranging from submicroscopic cellular biology 


37 


to surgical methods for nerve regeneration -- illustrate well the continuity 

between "basic" and "applied" research: 

Unbroken lines of development changes [in science] are 
apt to go unnoticed by those most closely and continu- 
ously involved in them, and it usually is left to the 
historians later to trace them and package them arti- 
ficially into separate epochs, stages and phases. 

A similar artifact is the customary categorical dis- 
tinction between "basic" and "applied" research. No 
more realistic is the conceptual separation between 
"theory" and "practice". . . .All such distinctions 
are a matter of degrees of interest and focus and 
varying proportions in the mixtures of methodologies 
applied, but certainly are not properties of the sub- 
jects under study. As nature knows no pigeonholes, so 
knowledge, and the research leading up to it, consti- 
tute unbroken continua. That is to say, no borders, 
fence posts, or other signs of discontinuity are met 
along the roads from the most fundamental principles 
of physics to the most sophisticated devices of tech- 
nology. . . . from the most elementary discoveries 
in the cellular and developmental biology of animals 
to the prevention and cure of human disease. Pigeon- 
holing is plainly a managerial device for the conven- 
ience, expedience and efficiency in handling practical 
affairs in the infinitely graded diversity of the real 
world, however, there is no counterpart for the labels 
that designate the various pigeonholes. 

... Of course, curious and purposeful investigators 
and practitioners alike ignore straightjackets to 
their thoughts and searchings imposed by extraneous 
formalisms. They shuttle freely between the "basic" 
and "applied" directions of the research continuum. 


2.2: The Influence of Social Context on Biobehavioral Research . Contrary 

to the implications of the standard view, then, research and technological 
developments do not only, or even usually, flow unidirectional ly, from the 
scientist's laboratory bench to the patient's bedside or society generally. 
Rather, the directions of scientific and technological research are strongly 
responsive to societal inputs. 


38 


There are, once again, historical reasons for our too-ready acceptance 
of the standard view. In terms of recent history, we have been strongly 
affected by greatly increased effectiveness of curative medicine, during 
and after World War II. This improvement was the practical consequence of 
applying new discoveries in biochemistry and pharmacology, and soon spread 
throughout the whole world of tertiary, or hospital medicine. It drew Federal 
funds on a large scale, into the support not only of the NIH, but also of 
basic research conducted within industry and by academic scientists. For 
a time, indeed, it seemed that biochemistry , molecular genetics and related 
sciences held the crucial "keys" to the relief of human suffering of all 
kinds. The faith in the power of medical science to bring Utopia (expressed 
in Sinclair Lewis's Arrowsmith with special reference to microbiology) was 
easily extended to "the biomedical sciences" at large. So, Society v/as ad- 
vised to support basic biomedical research generously and uncritically, in 
the certainty that a better grasp of the inner secrets of Nature was the 
surest way of developing effective cures for human suffering. Knowledge 
would move from the esoteric domain of scientific understanding, where it 
could be pursued only on its own elusive terms, to the practical domain, 
where it would take the form of a cure for any ailment. 

Hence have arisen the widespread expectation, still widely current 
among the general public, that science would bring us a continuing stream 
of dramatic, and dramatically effective, improvements in curative somatic 
medicine. Given the exaggerated character of these expectations, however, 
any prolonged failure for the Conquest of Polio to be followed by an equally 
spectacular Conquest of Cancer, Heart Disease, etc. has been bound to generate 


39 


some disappointment about the underlying programs of biomedical research. 

Along with this disappointment, there has grown up also a concern about the 
social risks and responsibilities involved in the new powers of biomedical 
science, and about the dangers of authoritarianism implicit in the exercise 
of esoteric knowledge. 

Some of the recent disenchantment with biomedical research and the 
institutions that sponsor it also seems to stem from the illusion that all 
problems of health and illness can be solved by a "research blitzkrieg" -- 
an illusion that Rene Dubos addressed so eloquently in his book, The Mirage 
of Health . Alternatives to the standard, received models of the research 
process have begun to appear in the past 10 to 15 years, largely through the 
development of the "new" historical sociology (or social history) of science, 
which treats the enterprise of science not merely as an exercise of pure 
reason -- governed by its own procedures and progressing in isolation from 
its historical context -- but as an activity carried on by human inquirers -- 
partly as individuals, but largely within collective societies and institu- 
tions that interact with, influence, and respond to the larger society 
within which they function. The more complex and subtle analysis that is 
possible, given this newer perspective, avoids any suggestion that Science 
proceeds quite independently, and merely hands over its discoveries to 
Society as and when they occur: it focuses just as much on the interactions 

that take place at the interface between the activity of scientific inquiry 
itself and the goals, policies and activities of the larger Society. 

In order to put this new understanding fully to work, in support of policy 
making in the area of biobehavioral technology, one would need many more detailed 


40 


sociohistorical case-studies than yet exist, of representative episodes in 
which biological science, medical technology and the like have generated (or 
developed in response to) social changes. Here, we can proceed only on the 
basis of the material currently at our disposal. In the Appendices to the 
present report, we have sketched fuller analyses of three sample episodes; but 
we suggest that -- as a basis for future discussion and policy-making -- the 
Congress would do well either to undertake, or to commission, a fuller and 
more detailed series of such studies. (Dr. Comroe's study of cardiovascular 
therapies for the President's Biomedical Research Panel, and the "Traces" 
study of contraceptive techniques for N.S.F., are two instances of what needs 
to be done in this respect.) 

Topics for this kind of analysis might well include the following. (1) 
The development of microbiology and its relationship to the public health 
movement . As to this first example: it is clear, on the one hand, that the 

creation of bacteriology and related sciences during the second half of the 
nineteenth century had dramatic effects on Society, by way of urban sanitation, 
the control of waterborne infections and the like, with remarkable consequences 
for life expectancy in the general population. But it is equally clear that 
the social needs and demands that were met in this way antedated these scien- 
tific discoveries. (The squalor of the new industrial cities of the late 18th 
and 19th centuries v/as a topic for comment and satire at least from the time 
of Hogarth, and preoccupied many of the Utilitarian social reformers.) 

What is not yet clear is how far, and by what channels, the urgency of 
these social needs communicated itself to the microbiologists, and so stimu- 
lated the questioning that led to the scientific developments in question. 


41 


Significantly perhaps, much of the pioneer scientific work in this field was 
done in France, where -- as Joseph Ben-David has emphasized -- biomedical re- 
search v/as generally carried on under the wing of hospitals, rather than, as 
in Germany, at universities. Given the overall impact of modern microbiology 
on human health, indeed, it is surprising how little is yet understood even in 
this prototypical case, about the manner in which the science grew up and about 
the steps by which its discoveries were put to actual practical use. 

( 2 ) The biomedical and behavior al influence of 20th century bacteriology . 
Historically speaking, there is only one other case in which the social in- 
fluences of biobehavioral science have been demonstrated as clearly as in our 
first example: viz. the manner in which 20th century innovations in bacteriology, 

biochemistry and pharmacology have, firstly, led to the development of cures 
for -- in some cases, even to the virtual elimination of -- many of the infecti- 
ous diseases that had been scourges of humankind throughout history; and secondly, 
have given human beings the prospect of modifying and controlling their own psy- 
chological states. Once again, there was demonstrably a reciprocal interaction 
between science and society in this field. Though the first sulfonamides were 
available before 1940, the main head of steam behind the development of peni- 
cillin and its successor antibiotics developed during World War II, in response 
to wartime needs. 

However, the larger pattern of social processes, influences and interactions 
in which these antibiotics have played a significant part remains to be analysed. 
Among other things, of course, it includes the wide problem of world population. 

As many commentators have pointed out, population pressures are most directly 
the consequences, not of an absence of birth control, but rather of "death 


42 


control." (As for the current and prospective effects of psychotropic phar- 
maceuticals on individual and social welfare: certain of these are discussed 
below, in the Appendix on Behavior Modification techniques.) Here too, then, 
we are concerned with a complex and subtle network of interactions between, 
on the one hand, the changing patterns of 20th century life and public expecta- 
tions and, on the other hand, the priorities of biobehavioral research and 
development, both in the academic and public sectors and in industrial labora- 
tories. 

(3) The polio vaccine . It would be worth studying the development of 

vaccines for poliomyelitis in more detail than has been done, just because 
it seems at first sight to be a prime illustration of the "Bench to Bedside" 
process. Evidently, the actual discovery of the Salk and Sabin vaccines 
could scarcely have been accelerated by the mere injection of more public 
money into vaccine research: yet, it is necessary, even in such cases as 

this, to bear in mind the complexities of the research process and of the 
research community, as these affect the distribution of effort and atten- 
tion between different problems and lines of investigation, and the recep- 
tivity of the scientific community to novel ideas of different kinds. 

(4) The social context and influence of oral contraceptives . The 
development of the contraceptive pill not only illustrates the inability of 
scientific competence, by itself, to generate a socially useful technology. 

It makes clear, also, the value to basic science of the opportunities created 
by social needs and technological investment. For the pressure to develop new 
varieties of oral contraceptives came from the social side: from the concerns 


43 


of a few individuals who saw clearly the real human needs of millions of 
women. And the resulting emphasis on biochemical technology and clinical 
research gave a strong impetus to the development of steroid chemistry it- 
self, leading to the pursuit of new lines of basic research, and to the 
discovery of many new hormones and biochemical mechanisms hitherto unknown. 


Given what we already understand in outline about the interactions of 
Science and Society, such examples as these illustrate a number of signifi- 
cant points. To begin with: a certain tension must be recognized, between 

the "analytical" or "reductionist" methods proper to much scientific research, 
and the more "synthetic" or "holistic" approaches needed for a well balanced 
system of health service delivery. To cite E.H. Starling: writing in 1921, 

he warned of the intellectual dangers involved in carrying over reductionist 
habits of mind into clinical practice, in terms that call to mind Goethe’s 
earlier attacks on reductionist Newtonian science. 

The danger arose out of the fact that the method of 
physiology was, of course, largely analytical; the 
functions of the body were split up into their several 
parts and the conditions of each of these were studied, 
while the synthesis, which was much more difficult, was 
often forgotten. The physiologist in medicine played 
only with his pawn or his knight or his queen, whereas 
the clinician had got all the pieces in his hands. It 
was necessary for the physician to complete the work 
of the physiologist. While it was true that any advance 
of medicine on other than physiological lines would be 
chimerical, it must not be imagined that because they 
knew physiology they were aware of all the moves along 
all the files and ranks and diagonals of the chequered 
board. 


The strong concentration on a mastery of the "basic" or "precl ini cal " sciences, 
characteristic of medical education in the United States since the time of 
Flexner, thus exposes medical practice to dangers as well as to benefits. And 


44 


the recent shift of attention in the Congress and elsewhere, away from the 
mere promotion of the biomedical sciences and toward a greater concern with 
"health care delivery," can be seen as an attempt to redress this balance: 
an attempt to modify old institutions and create new ones, that will promote 
the public interest in "synthesis" as well as "analysis," in distributive 
justice as well as scientific truth. 

Again, we have to accustom ourselves to analysing the interaction of 
science and society in terms, not of oneway influences, but rather of reci- 
procally acting "feedback loops." Clinical and social experience, and the 
concepts developed to understand it, have a utility to basic science, as 
well as vice vers a; and new methods are needed to take advantage of these 
connections. It has been suggested, even since the Johnson Administration, 
for instance, that all sorts of desirable biobehavioral innovations may cur- 
rently remain "locked up" in the nation's scientific laboratories, instead 
of being developed and put into practical use. If there is any truth in this 
suggestion, the reason is not that the scientists concerned are indifferent 
to the possible significance of their work for clinical practice. Rather, 
it is that so few well established channels exist by which an understanding 
of clinical needs and problems can be "fed back" to the laboratory scientists, 
who as a result often remain unwittingly ignorant about the clinical potential 
of their discoveries. 

In this respect, acceptance of the Bench to Bedside model is self-rein- 
forcing, in ways that have unintended and undesirable social effects. To the 
extent that people underestimate the extent to which an understanding of social 
needs and demands can stimulate work in even the most basic of sciences, they 


45 


neglect the channels of communication through which biomedical and behavioral 
scientists might have the opportunity to learn more about the possible appli- 
cations of their work. In this way, they are led to ignore the need for new 
institutional connections, which could facilitate a "transfer" of new know- 
ledge into practice. 

Finally: in making the proposals we do in Chapter 5 below, about novel 

institutional arrangements for the management of biobehavioral science and 
practice, we see these also as ways of making available to the public at large 
the information that needs to be taken into account, if the current aspira- 
tions toward democratic participation are to have any fruitful result. Only 
in this way can we hope to create a situation within which politicians, scien- 
tists and the larger public will share a common perception of the opportunities 
(as well as the dangers) implicit in new biobehavioral science and technology; 
and so help to dissipate the fears and suspicions that at present cloud the 
attitudes of the public toward the scientific and medical professions, and 
vice versa. 













. 











































































47 


Chapter 3 

Public Interests and Attitudes 

3.1: Nineteenth Century Background . Public interest in scientific re- 

search and science-based technology is, of course, partly generated by 
expectations about the benefits to come than the growth of scientific 
knowledge, and those expectations are founded both on immediate experience 
and on more broadly based longer term assumptions about nature, human life 
and society. The peculiar course and circumstances of American history -- 
the establishment of this nation on a relatively unexplored and unsettled 
continent, as well as the intellectual traditions and urban-industrial social 
order it shares with Britain and Europe -- have done much to shape those as- 
sumptions. As a result, attitudes and institutions born early in the history 
of the Republic have had a persistent influence on American thinking, and are 
still at work, in seemingly paradoxical ways, is the arguments and apprehen- 
sions about science and technology being voiced today. 

One powerful foundation for public support of scientific and medical acti- 
vity in America has been the widely held view that natural and social resources 
are effectively boundless, waiting only to be tapped and utilized by human 
ingenuity. The ready availability of public land and the scarcity of labor 
(particularly skilled labor) encouraged this image of unbounded opportunity 
for much of the 19th century. In medicine, for instance, the absence of an 
educated elite meant that access to both professional education and professional 
care could at first be free of restrictions through licensing or formal insti- 
tutional arrangements. Whether this was advantageous or damaging to health is 
not the present question: what concerns us here is that medical and scientific 
enterprise made claims on popular loyalty and support. 


48 


To the extent that scientific education and research needed sustained 
support, a mixture of state and private patronage was generally seen as the 
appropriate means. And although these needs were modest by present-day scales, 
and even by the standards of the time, the low level of public funding is not 
an adequate indication of attitudes and expectations toward science and medi- 
cine. Patronage was concentrated on the development of libraries, scientific 
collections and learned societies, which in turn nurtured learning, while the 
responsibility for the protection of public health was also a matter of general 
concern. Often, the threats to health were perceived as having external origins: 
diseases such as cholera, imported from foreign shores, was particularly liable 
to evoke organized responses. At the same time, the promise of improvement 
evoked measures to insure full utilization of resources, without needlessly 
restricting inventiveness . 

On the whole, as science came to be identified with growing material 
prosperity based on useful knowledge, the middle decades of the nineteenth 
century were characterized by increased public commitment to the practical 
application of science. The establishment of the Patent Office, and the fund- 
ing of agricultural research through the Morrill Act and the land-grant college' 
exemplify this confidence. Meanwhile, quarantine laws, and regulations to pro- 
tect the public health, sought adequate control that would not exert undue re- 
striction of commerce. 

By the turn of the century, both applied science and medicine had regis- 
tered striking achievements; and these successes gave substance to the reformed 
curriculum for both undergraduate and professional education. Engineers who ha^ 
earlier learned their art in the field could now be educated in specialized 


49 


institutions, and medical training came to rely less on apprenticeship and 
more on laboratory and classroom instruction. While graduate degrees in pure 
science were still relatively rare, applied science and medicine increasingly 
led to productive and rewarding careers and social roles. By 1915 Charles 
William Eliot, former president of Harvard University, could propose "that 
this method of preventive medicine is the one which should be universally 
applied for the defense of society against the evils which afflict it -- such, 
for example, as alcoholism, prostitution and war." 

While, in the arena of social policy, anxiety about possible conflicts 
between public good and private enterprise sparked debates about the regula- 
tion of business and commerce, it still seemed almost ludicrous to suggest 
that the scientific and medical enterprises could pose similar threats. On 
the contrary, science was most often pictured as the guardian of public wel- 
fare, and philanthropic activity which had formerly been promoted in charita- 
ble and moral terms now sought legitimacy through identification with medicine 
and science. The fear that science might be hobbled or corrupted by political 
intrusion seemed far more serious than the suggestion that science and tech- 
nology could endanger health and welfare. Both the growing community of science- 
trained experts and the lay public argued that physicians and applied scientists 
should be allowed to pursue truth freely, in the interest of their clients. 

While this sentiment of support did not generally lead to substantial public 
funding, here too there were indications of a shift in the pattern of support 
to science. 


The newly professional image of science and medicine was visible in the 
establishment, and growing authority, of professional societies; private fortunes 


50 


amassed through business and industry found ways of linking private enter- 
prise to the support of science and medicine, sharing the opportunity for 
"doing well by doing good"; and the federal government moved beyond the limits 
of its earlier commitment to the health care of merchant seamen and the armed 
services , to protect the health of the civilian population at large. The 
establishment of the Children's Bureau (1912), the support to states for 
venereal disease control through the Chamberlain-Kahn Act (1917), and the 
Sheppard-Towner Act of 1921 providing "matching funds" for the protection of 
maternal and child health, were indications of a modest yet novel investment 
by government in medicine. Yet at no level was the public support of scienti- 
fic and medical research primarily vested in the government and, particulatly 
in the health area, private institutions and foundations remained the most 
important resource, as illustrated by lay leadership of the National Tuberculo- 
sis Association (1904) and the American Society for the Control of Cancer (1913 

This diversity in the sources of support for science should not, however, 
be read as public hesitation to endorse science. Rather, the evidence suggest? 
that scientists themselves were not yet fully prepared to accept the burden 
imposed by heightened public hopes and expectations. The early decades of the 
twentieth century, in fact, found the public unambiguously enthusiastic about 
the achievements and promises of scientific and medical research. Where pro- 
blems remained, it appeared that the solutions would lie in the spread of 
scientific knowledge and practical know-how. 

3.2: The Contemporary Situation . It was the economic depression of the 

1930s and the destructive effects of World War II (particularly the Atomic M 
that first aroused active and widespread fears that science had unleashed po 


51 


beyond human control. While ever larger commitment of public resources brought 
undeniable achievements, the magic of science and medicine was not only inspiring 
but also terrifying. The economic costs of big science and big medicine spiraled, 
but the social costs were more difficult to evaluate: indeed, the highly techni- 
cal character of much scientific research often led Americans to despair about 
fashioning adequate safeguards for the application of this knowledge. In some 
important areas public policy seemed to rely on specialized knowledge that limited 
the participation of laymen in the process of decisions. Atomic power both mani- 
fested and symbolized the close connection between the good and evil forces at 
science s command — abundant energy could mean either a richer life or the 

destruction of life — and this was only one of the many possible areas of con- 
fl ict. 

Ever, where there had at first seemed no room for "unintended consequences" 

(as with penicillin) unexpected dilemmas appeared. While syphilis could be 
treated simply and effectively for the first time, for instance, freedom from 
the fear of the disease might encourage sexual contacts on a scale that challenged 
traditional professional and personal values. Meanwhile, as medical prowess in- 
creased, the relationship between physician and patient altered. Whether indi- 
vidual care or community health was the focus of attention, there emerged pro- 
blems of relative cost and benefit, contradictions between social gains and per- 
sonal values, and the contesting claims of differential needs and expectations. 

As a consequence of these dilemmas and ambiguities, public perceptions 
of science and medicine are in a state of some uncertainty. To begin with, it 
is no longer clear that, in regard to the value of scientific knowledge, there 
is any longer a unified "public opinion:" different sections of + he lay public 




now seem to take very different points of view. On somelevels, the older 
enthusiasm for know-how still preserves its force: on others, a r.ew skepti- 

cism and distrust seem to have taken hold, though it is hard to tell how 
deeply it is rooted in the public mind. Any discussion of public policy for 
biobehavioral technology needs, accordingly, to acknowledge the new complexi- 
ties both in the actual tasks of technology and in public expectations and 
attitudes toward its practical application. 


What do we know about the current state of these attitudes and expecta- 
tions? There have been several studies of public opinion about science and 
technology in general, but little study specifically of biobehavioral tech- 
nology or lay understanding of it. Before reviewing the major themes emerging 
from available studies, we need to consider some general issues about opinion 
research, in particular as it concerns public views about science and techno- 
logy. 


Four issues are worth touching on here. First: most opinion research has 

been conducted without any specific information about the respondent s know- 
ledge base." This can be important since, by using respondents who have no 
relevant information, it is possible to solicit opinions in ways that in fact. 
create them. For preference, one should first assess the state of knowledge 
of a given population, and then look at its opinions, in light of that l now- 
ledge. Instead, the closest that opinion research comes is to give respondents 
the option of answering that they don't know, or have no response. In the I 
available studies of public opinions about science and technology, the proper- 
tion of the population reporting a "do not know" or "no opinion" response is 
above average, compared to most public opinion surveys; and those responses ; 


53 


differ significantly with the income and education of the respondents. In 1974, 
the National Science Board, for instance, conducted a survey of public atti- 
tudes about science and technology. Asked a question about the general harm 
or good resulting from science and technology, 20 percent of those with less 
than a high school education had no opinion, while only 4 percent of those 
with some college experience had no opinion: likewise, 21 percent of those 
with family incomes under $5,000 per year report no opinion, while only 6 per- 
cent of those with an income in excess of $15,000 reported no opinion. So, 
where definite opinions were reported, they were apt to reflect the views of 
the more highly educated and wealthier segments of society. In future studies, 
it would be helpful to analyse better both why the poorer and less educated 
segments in society more often report no response or no opinion: whether this 
is because they are less informed, less interested, less certain of their 
opinions, or whatever. 

A second problem is that most opinion studies about science and technology 
have tended to lump together all different sciences as "science" and all types 
of technologies as "technology" -- to say nothing of blurring the distinctions 
one might make between science and technology -- instead of soliciting opinions 
about specific scientific or technological issues. Yet behavioral science re- 
search strongly suggests that, as a predictor of behavior, the utility of a 
response is directly related to the specificity of the opinion solicited. The 
more that opinion studies ask in quite general terms about "science" or 
"scientists" or "technology," rather than about specific sciences or specific 
technological developments, the less likely is it that the opinions solicited 
will be significantly related to behavior. 


54 


A third, related issue is the problem that, where public opinions have 
been solicited about "science," these have drawn principally on a public 
image of the "hard" (or physical) sciences, rather than on ideas about the 
biological or social -behavioral sciences. (There seem to have been no studies 
of public knowledge, and opinions, about specific aspects of biological, be- 
havioral or social science, or their associated technologies.) 

Finally, while it may be informative to know what "the public" thinks 
and feels about science and technology, we must eventually face the question, 
how public knowledge and attitudes toward science and technology bear on the 
determination of public policy. The public has a variety of mechanisms for 
participation — some formal, others informal -- and it does not represent 
a single coherent, homogeneous group: indeed, so far as we can yet tell, lay 

participation in science and technology involves many of the same processes 
and mechanisms that determine lay participation in other aspects of American 
society, such as voluntary associations and political parties. If this is the 
case, the opinions of some members or groups will be much more important fot the 
development of science and technology policy than those of other societal groups 

3 # 3 ; The Public and Science . To begin by looking at public attitudes 
toward science: the 1974 opinion survey for the National Science Board investi- 

gated public preferences about tax expenditures for different types of science 
and technology. As shown in Table 1, science and technology leading to imp^ovec 
health care was most highly favored, while scientific and technological activi- 
ties leading to improved weapons for national defense received least support.! 
As the National Science Board report noted, these data must be interpreted with 


55 


TABLE 1 

In Which of the Areas Listed Would You Most Like to Have Your 
Taxes Spent for Science and Technology? 

Percent Choosing Area* 
1974 

Improving health care 69 

Reducing and controlling pollution 50 

Reducing crime 58 

Finding new methods for preventing and 

treating drug addiction 48 

Improving education 48 

Improving the safety of automobiles 29 

Developing faster and safer public transporation 

for travel within and between cities 26 

Discovering new basic knowledge about man 
and nature 21 

Finding better birth control methods 18 

Weather control and prediction 14 

Space exploration 11 

Developing or improving weapons for national 
defense 11 

No response 3 

(Adapted from Table, p. 148 in Science Indicators, 974, 

National Science Foundation, 1974.) 

* Multiple responses were accepted. 


56 


care. They may reflect merely "areas of general concern to the public" rather 
than "the possible specific role of science and technology in dealing with" 
these issues. 

There is another problem which exists with these data also. For example: 
while the public may support research to "reduce crime" in general, if this 
involved placing a special detention facility in a given community, they e would 
probably be much less support for this measure in that community. This general 
principle, that private interests sharply modify general opinion support, pro- 
bably holds for most of the issues listed in Table 1, and suggests that opinion 
studies of this kind would be more informative if they paid more attention to 
contextual considerations of kinds that affect the personal significance of chi 
issues. 

We may turn now to the recent survey by Etzioni and Nunn of the public 
opinion literature about science. They begin by noting that, within the in- 
tellectual and scientific community, current views about how the pub! ic sees 
science, scientists, and the role of science in society are mixed but predomi- 
nantly negative. (They cite, for instance, Jerome Wiesner's concern about the 
"deep distrust of science and technology expressed by many in our society. ) 

In sharp contrast, a number of actual studies suggest that, while there has be< 
some "erosion" of the earlier faith in science, a significant part of the publ 
still views science as a worthwhile and socially valuable enter pt iso, and t e 
public image of scientists generally remains one of respect and trust. True: 
opinion has been shifting somewhat in directions unfavorable to science. In 
1957, for instance, 43 percent of the public felt that science changes our way 
of life too fast and 23 percent saw it as a threat to people's ideas about rig^ 
and wrong; but by 1964 the percentages agreeing to these positions had 


57 


to 57 and 42 percent respectively. But, taken overall, the national survey 
results compiled by Etzioni and Nunn continue to show general public confidence 
from 1966 to 1973, in a number of "institutional areas," including science. (See 
Table 2.) In all the institutional sectors listed, there has been some loss of 
publ ic confidence, but the 19 point loss for science, from 1966 through 1973, 
is comparatively moderate. 

So v/hile there has been some increase in public concern about the impact 
of science, scientists as an occupational group have fared comparatively well 
in terms of public "prestige." According to the NSB study, in 1947 the public 
ranked scientists second in prestige, behind physicians alone, and they obtained the 
same ranking in 1974, also. 

Again, while the public may have expressed greater concern about the im- 
pact of science on beliefs about right and wrong and rates of social change, 
a substantial majority still consider the net effect of science as good. Taking 
science and technology together, some 75 percent felt that science and techno- 
logy had changed life for the better in 1974, as compared to 70 percent in 1972. 

Only 5 percent saw a overall change for the worse. Correspondingly, 56 percent 
described their general reaction to science and technology as one of satisfaction 
or hope in 1974, while 5 percent described it as one of fear or alarm. In 
assessing the benefits of science and technology, the public saw improvements 
in medical care as the most significant: their largest worries about the impact 

of science and technology had to do with its environmental impact. And while 
in 1974 fewer people than in 1972 felt that science and technology could solve 
most of society's problems (such as pollution, disease, drug abuse, and crime) 
nearly 25 percent still held such faith in science and technology, as compared 


58 


TABLE 2 


Percentage of the 

Public Indicating "A Great 

Deal" of 


Confidence in 16 

Institutional Areas: 1966 

vs 1973 



Year of 

Poll 

Change 

Insti tution 

1966 

1973 

1966-1973 

Medicine 

72% 

54% 

-18% 

Science 

56 

37 

-19 

Education 

61 

37 

-24 

Finance 

67 

— 

— 

Rel igion 

41 

35 

-6 

Psychiatry 

51 

— 

— 

U.S. Supreme Court 

51 

32 

-19 

Military 

62 

32 

-30 

Retail business 

48 


— 

Federal executive branch 

41 

29 

-12 

U.S. Major companies 

55 

29 

-26 

Congress 

42 

23 

-19 

The Press 

29 

23 

-6 

Television 

25 

19 

-6 

Labor 

22 

15 

-7 

Advertising 

21 

— 

— 


(Adapted from Table 3, p. 194 in A. Etzioni & C. Nunn "Public Apprecia- 
tion of Science in Contemporary American," Daedalus, vol . 103 (1974)1 
pp. 191-206.) 


59 


with 30 percent in 1972. Finally, even though in general the public is some- 
what more worried about science and technology today, there still does not seem 
to be much support for imposing stronger controls on them. For example, of 
the public sampled in the 1974 study, 28 percent felt "that the degree of con- 
trol that society has over science and technology should be increased," while 
46 percent felt less control would be desirable. 

While the larger public has maintained its support for science in recent 
years, there nonetheless exist segments of the public that are significantly 
disaffected toward science. Who are these people, and what is the source of 
their disaffection? 

The 1974 NSB study found that, in terms of age, significant disaffection 
occurred chiefly among the elderly (60 plus); but the major differences in 
opinion about science were related to levels of education and income. For 
example: in 1974, while 71 percent of those with some college education felt 

that science and technology do more good than harm, only 54 percent of those 
with less than a high school education expressed this opinion. Likewise, 70 
percent of those with an income in excess of $10,000 were positively disposed, 
but only 58 percent of those with lower incomes. Etzioni and Nunn reached 
similar conclusions. While science has lost some public support, they noted 
the largest disaffection "among politically weaker, less informed, less edu- 
cated groups." 

In passing, it is worth noting a concern voiced by Etzioni and Nunn. As 
we remarked, little is known to indicate how well informed the public is about 
science; but it appears that the public is in need of much more information. In 
commenting on the level of public knowledge, Etzioni and Nunn wrote: 


60 


The percentage of respondents who did not know how they 
felt about a given institution provides a rough estimate 
of its remoteness from the public's mind. Compared to all 
other institutions in 1973, science received the highest 
percentage of "don't know's" (10 percent of all respondents 
and from 15-20 percent of low-status respondents) . . . 

This suggests that science might stand to gain respect by 
explaining to the public more fully what it is and what it 
does. Indeed, this would seem to present an important edu- 
cational challenge to science, since those for whom science 
is most remote have similar social backgrounds to those 
least confident in science. 


While it may be important that policy makers and scientists learn as much as 
possible about publ.ic views of science, there is thus a considerable need, 
also, for the public to learn more about science. 


3.4: The Public and Technology . Let us now turn to review studies of 

public opinion about technology. As we remarked earlier, these have in general 
failed to separate out different types of technology, or even to consider how 
far the general public even views science and technology as separable. The 
National Science Board studies of 1972 and 1974 phrased all their questions 
in terms of "science and technology." Etzioni and Nunn claim that the "over- 
whelming majority of the public seems to confuse science and technology and 
sees science in a very technological, instrumental light." But La Porte and 
Metlay believe that "the public makes a distinction in their evaluations of 
the outcomes of scientific work and technological work." The work of La Porte 
and Metlay is based on a random sample of California adults largely similar to 
a national sample, and seems to provide some data for attempting to disentangle 
public opinions about science and technology respectively. 

They note, for instance, the concern expressed by leading scholars and 
scientists (such as Edward Shi 1 s and Robert Morrison) about dwindling public 


61 


confidence in, and respect for technology and technologies. In relation to 
such issues as supersonic airplanes and the environment, there seems to be a 
"growing uneasiness about technological matters among a generally acquiescent 
public." Yet their own public opinion survey has less clear results. Thus, 
they found that, while there was strong support for pure science, the public 
felt more concern about the applications of science or technology. When 
asked if they agreed with the idea that basically science was good, but the 
uses of science were problematic, 75 percent agreed. Further, when asked to 
comment on the view that attempts to control inventions available for public 
consumption would lead to a worsening of life, only 37 percent agreed. Ap- 
parently, while their respondents considered that science should be permitted 
considerable latitude, some control over technological developments were neces- 
sary. 


Certainly, the public seems to have priorities for determining what 
constitute more or less desirable technological developments. About 61 per- 
cent of La Porte and Metlay's respondents, for instance, regarded technologi- 
cal developments leading to an increase in employment as "extremely important." 


TABLE 3 

What Are the Important Values to be Considered 
in the Implementation of Technology? 


Goal Ranking 

To increase employment 1 

reduce pollution 2 

make life enjoyable 3 

reduce taxes 4 

improve lot of poor 5 

improve U.S. image abroad 6 

increase leisure time 7 


(Adapted from Table 3, p. 124 in T. La Porte and D. Met! ay, "Technology 

Observed: Attitudes of a Wary Public," Science, vol . 188, April 11, 1975, 

pp. 121-127.) 


62 


In this respect, the La Porte and Metlay study of public attitudes toward 
technological development mirrors the findings outlined above concerning 
publicly acceptable rationales for science. In addition, it turned up a 
number of general conclusions regarding the public image of technology. 
For example: 

(a) Expertise of a technical nature is highly regarded, and 
is seen as legitimately "exercising ... a great deal of 
influence ... in selected technological areas." 

(b) Governmental leaders are given considerable less support 
than technological experts, and are seen by the public 
as exercising influence in too many technological areas. 

(c) Business leaders "received little or no confidence, and 
were perceived as influential in four of six developing 
technological areas." 

(d) While viewing itself as the least involved in six major 
developing technological areas, the public viewed "itself 
as the 'actor' most entitled to be involved." 


Given the observation that the public generally is more supportive of 
science than of technology, we might ask what are the sources of concern about 
technology, and in what segments of the population is it most pronounced? A 
number of factors evidently feed into this concern. Of particular import have 
been the increasing impact of various technologies on our way of life generally, 
and on our environment in particular. Within the domain of medical care, the 
press has given much attention to the economic and ethical problems posed by 
a variety of health technologies. At the same time, the view of technology pre- 
sented in the mass media has been disjointed and confused. Early life extending 
procedures, such as heart transplantations, were first hailed in the media as 
major triumphs; only later were the legal, economic, and socicpsychological i ,su 
examined by the press, and only then did the public begin to appreciate 


63 


the limitations of such technological developments. 

Finally, the rise of interest and advocacy groups is providing the 
public with more information about significant technological developments. 
Such groups insure that, when scientists or experts speak up on both sides 
of a complex issue, both points of view can reach the wider public; and, 
in this way, the public may get a better sense of the political nature of 
science and technology, and so acquire more sophistication about the issues, 
and recognize that scientific and technological changes are amenable to some 
means of control . 


We remarked earlier that major dissatisfaction with science and tech- 
nology, taken together, occurs primarily among the poorer, the less educated, 
and the elder segments of society. The study by La Porte and Metlay suggests 
that, with respect to technology alone, the greatest alienation -- and the 
largest support for political control of technology -- are to be found among 
younger respondents, and those who define themselves as politically "liberal." 
As they note, 


The particular distribution of age and political identi- 
fication suggests that those who are young and who identify 
themselves as "liberal" form the core of potential opposi- 
tion to technological development and that such opposition 
is at least in part a function of different value pre- 
ferences. The associations between political identifi- 
cation and attitudes about technology, distrust of deci- 
sion-!'. aking, and concern for environmental impacts all make 
this point. 


So, it seems that opposition to science on the one hand, and to technology on 
the other, may be based to some extent in different parts of the population. 
In addition, the disaffection with science -- being found most often among 


64 


economically poorer, less educated and older people -- may not provide a base 
for sustained political intervention. Opposition to technology, on the other 
hand, appears to be commoner among groups having potential political signifi- 
cance. 

3.5: Conclusion . The studies surveyed in this report suggest some pro- 

visional conclusions about public views on science and technology. The public 
does seem to entertain somewhat different views on science and technology, 
when asked questions which emphasize the difference. In general science is 
viewed in a more favorable light than technology. 

The public appears to be concerned about both the direct and indirect 
impact of science on society, and more so about the impact of technology. At 
the same time, it is aware of the benefits that have resulted from scientific 
and technological activities. And, the public appeals to definite but mixed 
values in legitimating the social worth of science and technology. In the 
absence of major changes the public will probably continue to support science 
strongly, although there may be increasing calls for action to regulate or 
control technology. Certainly, the public now feels it is one of the most 
disenfranchised groups in relation to policy decisions about science and tech- 
nology, while seeing itself as having a strong right to influence such deci- 
sions. 


To the extent that the public views biobehavioral science and technology 
in the same way as science and technology generally, these general conclusions 
presumably hold equally for them, too. However, since biobehavioral technology 


65 


is directly or indirectly related to the improvement of medicine, public 
anxiety may be less than in areas like environmental pollution or supersonic 
aircraft. The public has much interest in, and gives great support to, health 
related or medical science and technology: there may be concern about the costs 

of health care, but the public still strongly supports research aimed at solving 
problems that threaten life or health. 

However, it is apparent that we need further studies which focus speci- 
fically on biobehavioral science and technology. Not only ought public opinion 
be solicited in this area, but the level of public awareness about such issues 
as behavior modification and genetic engineering needs to be surveyed. Finally, 
it would be useful to assess not only the nature of public knowledge and views 
about biobehavioral science and technology, but also their views about how they 
might participate in the regulation of biobehavioral applications. 








67 


Chapter 4 

The Ethical and Legal Chan n eling of Biobehavioral Technology 

Biomedical and behavioral research and practice are currently matters 
of intensive professional review, public discussion, and policy debate in the 
United States. Ideally, a social policy for channeling research on biobeha- 
vioral technology, as it moves through the spectrum from laboratory and human 
experimentation to regular use, ought to meet two separate requirements. It 
should provide rewards for developing new therapeutic practices based on 
scientific knowledge, and it should also create controls sufficient to pro- 
tect the public at large from ineffective or unsafe procedures, while securing 
the personal rights of individuals, both as experimental subjects and as patients. 

Historically, the scientific and medical professions have operated with 
considerable autonomy: this autonomy has been part of an implicit "social 

contract" between the professions and the larger society. In the field of 
therapeutics, this "contract" has included an understanding that biomedical 
and behavioral scientists will monitor the introduction of new therapeutic 
methods and regulate the use of experimental procedures on human subjects, 
especially patients. But, in recent years, this professional autonomy has 
been increasingly limited by the imposition of extra-professional controls 
and channeling mechanisms at the national, local, or institutional level. 

The controls that channel the course of biobehavioral technology, whether 
facilitative and constraining, are numerous in their nature and sources. While 
we shall here deal particularly with ethical and legal controls, it is necessary 
to bear in mind that the character and operation of such controls significantly 


68 


reflect the social milieu in which biobehavioral research and practice are 
conducted at a given historical juncture. Prevailing social values and public 
attitudes strongly affect the types of channeling mechanisms generated within 
the professions at any time, or imposed on them by external sources. Thus, in 
recent years, public policy -- as promulgated by legislation, regulatory agen- 
cies, legal rulings, and guidelines -- has tended to emphasize the "constraining" 
aspects of channeling mechanisms, to the neglect of their "facil itative" aspects. 

This current emphasis upon constraints reflects a complex interaction 
between several features of the current public milieu. In recent decades, 
science and medicine have been increasingly "demystified" and "secularized," 
and researchers have been increasingly portrayed as competitive, political 
human beings engaged in work that is largely routine and often boring. In this 
connection, it is illuminating to contrast the image of research conveyed to 
the layman in Sinclair Lewis' classic, Arrowsmith , with that conveyed by more 
recent works such as James Watson's The Doubl e Hel ix and Joseph Hixon's The 
Patchwork Mouse . Science and medicine have also come to be perceived as "big 
business": as a complex, technologically sophisticated, and highly expensive 
enterprise, and one senses the revival of a populism that is in part expressed 
as a conflict of interests between the "little" citizen and "big" science or 
medicine. These populist concerns about individual autonomy, about our ability 
to control the future, and about the social consequences of science and tech- 
nology, have helped to shape the types of control mechanisms imposed upon bio- 
behavioral research and technology. 


While Americans still seem confident of our general ability to control 
the future, and thereby avert many types of potential risks -- particularly in 


69 


health-related areas -- they seem to have declining expectations about major 
"breakthroughs" in the biomedical and behavioral areas. As a result, indi- 
viduals are less willing to place themselves significantly at risk, for what 
they perceive as relatively small potential research benefits. This "risk- 
aversiveness" is encountered in many other areas of contemporary life also. 

But people's perception of risk is related to what they see as the source of 
that risk, and there is evidence (from the popularity of Frankenstein to cur- 
rent fears about recombinant DNA and behavior control) that such risks are 
perceived as particularly threatening when they originate in "science." 

Finally, both the perception of risk and willingness to accept risks 
are affected by the level of the problem being addressed. When a major bene- 
fit has yet to be attained, there is greater willingness to assume often un- 
known risks: once that benefit is realized, relatively smaller known risks 

often arouse anxiety. Thus, the great desire for effective anti-schizophrenic 
drugs legitimated the testing and licensing of the powerful phenothiazine, 
chlorpromazine (Thorazine), despite adverse side-effects; but, now that an 
established armamentarium of major tranquilizers is available, there is 
greater concern to protect recipients against such side-effects as tardive 
dyskinesia. (Comparably, the potential risks from oral contraceptives were 
initially outweighed by the greater risks of unwanted pregnancies; but now 
that effective oral contraceptives are available, there is greater concern 
about the relatively smaller risks from such side-effects as endometrial 
carcinoma. ) 

Such public attitudes and expectations, though discussed only briefly 
here, can strongly affect the types of social control mechanisms that do, 


70 


and will, direct the course of biobehavioral science and technology, and so 
determine whether there is an equitable balance between facilitation and 
constraint. 

4.2: Ethical and Legal Channeling Mechanisms . At the outset, then, ethi- 
cal and legal controls cannot be adequately assessed unless one considers them 
in their social context; thus, the preliminary classification set out in Table 1, 
below, includes various types of societal influences (such as inputs from the 
public) that fall only marginally within the "ethical" and "legal" categories. 
Evidently, all of these types of channeling mechanisms do not and could not 
conform to a single, monolithic model; and different types of mechanisms have 
quite different merits and defects for different purposes. 

Starting from a consideration of the drug and surgery models: one can 

classify channeling mechanisms according to their source or locus -- individual, 
professional or extra-professional . Individual controls, or ethical norms, 
clearly affect the conduct of biobehavioral research and practice; professional 
controls range from the scientist's or physician's own professional training 
and socialization to mechanisms utilized by groups of professionals within 
institutions; while what one may term extra- p rofessional controls or channeling 
mechanisms may derive their authority from administrative, legal or legislative 
sources . 

We can classify and analyze these channeling mechanisms further, in terms 
of their varied interactions and effects on various facets of biobehavioral 
science. Controls may operate formally or informally. Informal controls 
are those that operate primarily through interpersonal contact, and the con- 


71 


sequences that the professional sees as flowing from the approval or disap- 
proval generated in that contact. Formal control mechanisms operate in a 
more structured and codified manner, through more clearly defined institu- 
tions or channels. As a glance at Table 1 indicates, many controls have 
both formal and informal components. Thus, for example, an investigator's 
decision about when to initiate research involving human subjects will be 
influenced by his own professional contacts and personal judgments, and by 
collaborative peer relationships, as well as by formal processes involving 
the funding agencies, regulatory bodies, or institutional review boards. 

Another useful distinction is that between channeling mechanisms that 
operate "before the fact" and "after the fact." (In human experimentation, 
for instance, both informal and formal ethical controls are instances of 
"before the fact" controls.) When formal approval is required before ini- 
tiation of a research project -- as with FDA permission for clinical trials 
of a new drug -- persons or groups other than the investigator are also re- 
sponsible for assessing benefits and risks. When only subsequent review is 
expected, as in the review of a new surgical procedure by a hospital mortality 
or tissue review committee, the investigator is in jeopardy only if a risk 
eventuates and harm occurs. Malpractice law is a good example of "after-the- 
fact" controls: these operate most commonly and effectively in the medical, 

rather than the behavioral area, probably because it is harder to prove risk- 
related injury in the behavior area. For basic science the analogue to mal- 
practice is the law of torts, which imposes on persons an obligation to 
provide redress if they negligently damage another person or his property; 
but, because basic scientific research creates immediate risk to far fewer 


72 


people than biomedical research or practice, the tort laws serve as a much 
less powerful constraint than malpractice law. 

The United States legal tradition is on the whole weighted in favor 
of promoting innovative procedures. At most, the innovator personally, or 
users of a product, may have to pay damages for legally compensable harm; 
but this constraint is often weakened by limitations on the kinds of harm 
that are compensable, by the difficulty of establishing causation, and by the 
problem of assessing relevant damage. In medical research, the burden has 
been somewhat shifted by an increased use of regulatory mechanisms requiring 
prior approval, to a point at which the regulatory agencies, instead of balancing 
facilitation against constraint, have in some cases a predominantly constrain- 
ing function. 

While legal and legislatively-based regulatory controls are formal 
and extra-professional in nature, ethical controls are predominantly infor- 
mal, and derive from the individually and professionally instilled values 
and attitudes of those engaged in biobehavioral studies. Normative ethical 
codes, stating what ought to be done in research involving human subjects, 
have been promulgated by many professional groups since the drafting of the 
Nuremberg Code in 1947, and have gained regulatory stature since 1966 in the 
Public Health Service's Policies and Procedures for the Protection of Human 
Subjects. These PHS regulations, coupled with the increasing public and pro- I 
fessional attention to ethical issues, have greatly increased awareness of 
and sensitivity to ethical channeling mechanisms. However, there is a 
documented variability in the exercise of formal ethical controls by peer 
review mechanisms, and many areas -- particularly basic research areas, and 


73 


many spheres of behavioral work -- do not fall under the purview of formal 
ethical controls. Thus, the exercise of both facilitative and constraining 
ethical controls rests predominantly with the individual researcher. 

In his book Reason and Conduct , philosopher H.D. Aiken analyzed four 
levels of moral discourse, an analysis that illuminates consideration of the 
sources and effects of ethical controls in the biobehavioral field. At Aiken's 
first level, called by others a "gut level response," we respond emotionally 
to whether or not we like what is going on. This level is often seen in mass 
media coverage of ethical issues in biobehavioral technology; and, all too 
frequently, in discourse among professionals as well. Aiken terms the second 
level the "moral" level, v/here discourse speaks, in a here and now, to the 
question, "What should we do in a particular situation?" Level three is Aiken's 
"ethical" level, moving beyond the existential concerns of level two to a con- 
cern with the general principles by which we justify our actions in particular 
situations. Finally, Aiken writes of the "post-ethical" level, at which we 
address the question of why we should be moral at all, why we should care 
about our fellow humans and what is done to them. 

The issues arising on this fourth, "post-ethical" level are difficult to 
articulate, but it is these broader human concerns that ultimately generated 
the establishment of such bodies as the National Commission, as well as the 
current bioethics movement more generally. We can discuss principles at Aiken's 
third, or "ethical" level with greater care and familiarity: such principles 

as individual autonomy, personhood, accountability and truth-telling, or the 
value of knowledge. These principles we attempt to apply as level -two "moral" 


74 


or normative guides to action in particular situations, in which we have to 
assess risks and benefits, obtain informal voluntary consent, be accountable 
for the short and longer-term consequences of our work, or whatever. 

4.3: Discussion . The preliminary classification of channeling mechanisms 

presented in Table 1 is intended principally to illustrate their complexity, 
and the need for a clearer definition and deeper assessment of professional 
practices and social policy in biobehavioral technology; and it raises more 
questions than it answers. We need to understand more fully, for example, how 
each type of control applies, and with what effects, to specific areas. Thus, 
one could use our classification to analyze how the exercise of any given con- 
trol will affect different types of research or practice, ranging across the 
spectrum from basic research (e.g., recombinant DNA) to such applied, nonthera- 
peutic behavioral procedures as those of sex therapy. That is, one can cate- 
gorize the various goals of biobehavioral science and technology; and, having 
made policy decisions about the desirability of their pursuit, systematically 
assess which combination of channeling mechanisms will most effectively facili- 
tate, or check, the goal's attainment. 

As noted earlier, the differences between the various mechanisms that 
channel innovations in drug therapy and surgery illustrate the diverse ways 
in which biobehavioral technology is controlled, and the factors that should 
be evaluated in proposing new controls. Innovations in drug therapy are subject 
to a system of formal control mechanisms, principally exerted from without the 
profession through the procedures and regulations promulgated and legally en- 
forced by the Food and Drug Administration (FDA). To move a new drug from 
laboratory study to clinical trials, and then to non-investigational u:c, 


75 


involves a long and complex process from animal toxicity studies through 
post-marketing requirements. Although directed primarily at the pharma- 
ceutical industry, as the usual "sponsors" of a new drug, these requirements 
obviously act too as powerful control mechanisms on the activities of the 
clinical investigator. (In addition to FDA regulations, two other formal 
control mechanisms affecting drug development are the PHS policies for re- 
search with human subjects, and the regional and national systems for moni- 
toring adverse drug reactions.) 

The processes by which the efficacy and safety of new surgical procedures 
are evaluated are not, by and large, subject to the same formal controls. Inno- 
vative surgery does not fall under the purview of any public agency. Again, 
the chief source of surgical innovations is the individual physician, rather 
than an industrial research organization, and this fact has an important 
bearing on the economics of regulatory procedures. Whereas the direct costs 
of developing and evaluating innovative drug therapies fall directly on the 
drug industry, and indirectly on the consumer, the formal evaluation of new 
surgical procedures would have to be financed in ways that have yet to be 
determined. 

Furthermore, except in the case of long-term expensive programs like 
organ transplantation, most new surgical procedures are not developed using 
federal research funds, and the application of institutional peer review 
mechanisms to innovative surgery is highly variable: it relies chiefly on 

ad hoc procedures established by local hospitals and medical groups, and 
their mode of operation depends very much on how the surgeon himself defines 
the "experimental" character of the procedure -- particularly on whether he 


76 


treats it as "research" or not. Again, with few exceptions (such as the 
international transplantation registry maintained by the American College of 
Surgeons and the National Institutes of Health) procedures have not up to now 
been developed for systematically collecting, analysing, and reporting data 
on the effectiveness and safety of given surgical procedures, old or new. 

In principle, however, the scientific issues raised by innovative surgery 
are no different from those raised by clinical research on any new treatment: 
whether drugs or radiation therapy, psychosurgery or acupuncture. To the ex- 
tent that a procedure is new and the evidence of its value inconclusive, the 
practice will not yet have been accepted within the profession. This being 
so, it should arguably be clarified or made the object of research designed 
to evaluate its effectiveness and safety by scientific standards. 

In the past twenty years, the general methodology for evaluating thera- 
peutic procedures has advanced greatly, and the controlled clinical trial has 
gradually evolved, using techniques such as random assignment, control groups, 
quantitative measures of change and advanced statistical methodology. But 
these procedures have rarely been applied to novel surgical procedures. 

There are a number of historical and practical reasons for this difference 
Some have to do with the training and "role-definition" of the surgeon, in con- 
trast to other types of physicians; others have to do with the problems involved 
using surgicals patient as "control." Again, to the extent that surgical inter- 
ventions are often more "dramatic" than drug interventions -- more apt to be 
used in desperate or emergency situations, where all other treatr.onts have 
failed -- there are certain differences inherent to the application ot surgical 


77 


and drug therapies. So, except for "after-the-fact" litigation, existing 
formal controls seem to be not as well adapted to the "each-case-on-its-own- 
merits" approach of surgery as they are to the drug-therapeutics approach. 

Nonetheless, such long-standing controversies as that over the efficacy of 
various procedures in the treatment of breast cancer -- particularly, the 
radical vs. simple mastectomy dispute -- underscores the importance of developing 
better systems of controlled therapeutic trials in the surgical field also. 

The formal controls governing drug research in the United States 
are, of course, the subject of current dispute, debate, and legislative pro- 
posals. Some analysts argue that the FDA's restrictive controls have created 
a medical ly-serious drug lag in the United States. A recent GAO report, by con- 
trast, urges stricter controls in the area of new drug testing and charges that 
the FDA is not adequately protecting human subjects or the consuming public, by 
failing to enforce compliance with its own testing requirements. Similar de- 
bates have arisen equally about both old and new surgical procedures: from 

hysterectomy and coronary byp to psychiatric neurosurgery. The 

high costs of technologically complex surgical care, together with the absence of 
rigorous data about the efficacy and' safety of many procedures, have generated what 
many see as the central ethical -- and economic -- issue in surgery today: that of 

"unnecessary" surgery. The need to resolve this issue is one factor that may impel 
more systematic clinical trials, for determining the efficacy of both innovative sur- 
gical procedures, and of those which are established but poc 4 *ly evaluated. 

4.4: Gone 1 us io n. The tasks of identifying the different channeling 

mechanisms at present influencing different types of biobehavioral science and 
technology, defining their components, and understanding of how and why they 


78 


take the form they do, are of more than academic interest: they bear directly 

on many aspects of research and practice that are matters of concern and policy 
decision both within and outside the professions. So, it is unproductive to 
debate the question of whether there are "too few" or "too many" controls in 
entirely general terms. Rather, we need to deal with more specific issues: 
e.g., how to define "innovative therapies," what criteria to use in determining 
the experimental -therapeutic status of new procedures, etc. And, in all such 
studies, we have to bear in mind the fact that "channeling" mechanisms can act, 
in different ways, either as facil itators o£ as constraints. Furthermore, we need 
to consider all the different parties affected by any new policy. Professional 
organizations, hospitals, medical schools, universities and research institu- 
tions, individual physicians, patients and their families, those financing re- 
search and practice, and the public at large, all have their own stakes in suchl 
a review. 

As we scan the spectrum of biobehavioral activities, and the diverse 
channeling mechanisms that do, or might, affect those activities, it is clear 
that no single set of control processes can apply to the whole field. At pre- 
sent, formal controls most strongly affect areas of research and practice that 
place recipients at some definable "risk." They are weakest, or entirely 
absent, in basic research areas and in what we have called "augmenti ve" be- 
havioral areas, where non-professionals play a greater role than elsewhere. 

In general, however, there is no comprehensive statement to be made about how 
well, or poorly, existing ethical and legal channeling mechanisms are succeeding 
in constraining or facilitating given areas of work; nor are we reedy to propose 
specific new controls, given our judgment that the nature and effects of c * . ■ . t i nc 
controls is not yet adequately understood. 


79 


Indeed, any proposed new channeling mechanism -- particularly a formal 
one -- should itself be regarded as an innovation, and evaluated against 
objective standards, just as much as a biomedical or behavioral innovation. 

We should ask, for example, how any new control will interact with existing 
controls; what its unintended side-effects may be; how it will affect the 
desired balance between advancing research and treatment and protecting the 
welfare of research subjects and patients -- not to mention the economic 
effects of instituting and implementing a new control. 

V.'ith these considerations in mind, we reviewed the various controls 
now governing biomedical and behavioral research and practice, and discussed 
-- in rather speculative terms -- the idea of a National Therapeutics Review 
Board, with sections for various areas of biobehav ioral technology. Our dis- 
cussion ranged over the need for and possible functions of such a board, its 
possible composition, status and authority, ways of avoiding a complex, uni- 
dimensional regulatory agency, and the nature of "appeals" processes. Rather 
than proposing any specific new control mechanism of this kind, we would recom- 
mend at this juncture that various groups, within and outside the government, 
initiate and/or continue systematic and detailed case studies on the effects, 
and effectiveness of controls in various areas. To help systematize and 
coordinate research and policy deliberations, some kind of "national clearing- 
house" is desirable, to coordinate and disseminate research results, legisla- 
tive proposals, etc. dealing with channeling mechanisms for biobehavioral 


science and technology. 


80 


TABLE 1 . Summary o f Channeli n g Mech anism s for 
Biobehavloral Science and Technology 


I . Individual . 

A person's value and belief system, as shaped by his or her culture, 
society, family, education, religion, etc. Major source of ethical 
precepts . 


1 1 . Professional . 

A. Scientist's/physician's professional training and socialization, 

including his role definition and professional values and beliefs. 

1. Are personal and professional values and beliefs congruent? 

2. Are there conflicts between research goals and societal ly- 
defined needs and values? 

3. Are there conflicts between research and treatment goals in 
clinical areas? 

B. Scientist's/physician's decisions about aspects of his work such as: 

- when to initiate basic research 

- when to initiate non-therapeutic research with human subjects 

- when to initiate therapeutic research with human subjects 

- where work falls on research to application spectrum. 

1. These decisions involve informal and formal criteria for 
evaluating need, short and long term risks and benefits to 
individuals and groups, and efficacy; all judgments that door 
should invoke ethical parameters. Particularly when human 
subjects may be at risks, we need to ask, what are the criteria 
for safety and efficacy, and who determines the adequacy of : 
the criteria and the evidence? 


81 


C. Peer Mechanisms . Examples of these controls, which operate both 
informally and formally, include the following. Other types of 
peer controls are listed under II, E. 

1. Pi'ofessional Certification Processes 

2. Participation in collaborative research groups 

3. Relationships in informal professional networks ("invisible 
colleges") 

4. Membership in professional organizations 

5. Codes of ethics established by professional groups 

6. Scientific and ethical criteria established by conferences 
and journals for presentation and publication of papers 

7. Professional recognition and award; such as the Nobel Prize 

8. Groups systematically collecting, evaluating, and disseminating 
research/treatment data (such as the organ transplantation and 
dialysis registries) 

D . Ethically -based re 1 at ionship s between r esea rchers and research - 

subjects in nontherapeutic and therapeutic research . 

There is a need to define the relationships that ought to and can 
obtain in basic research areas, such as recombinant DNA, where 
there is not a readily definable "subject at risk." 

E. Institutional Mechanisms . Professionals working within the various 
institutional settings where biobehavioral inquiries are conducted, 
such as hospitals, university laboratories, and industry, exercise 
various types of controls over their peers' work. Examples of those 
institutionally-based, professionally-exercised controls include: 

1. Staff meetings and clinical rounds 


82 


2 Peer review committees for research with human subjects 
(following the PHS guidelines for such research) 

3. Peer review committees for clinical practice, such as 
tissue, mortality, and utilization review committees 

4. Ethi cal /Legal Research and Advisory Bodies . A number of pro- 
fessional groups in both the private and public/governmental 
sectors, have come into being in response to the ethical, legal 
and social issues posed by biobehavioral technology. Represen:, 
tives of these professional groups are the Institute for Socictj 
Ethics and Life Sciences, the Kennedy Center for Bioethics, 
the National Commission for the Protection of Human Subjects, 
Biomedical and Behavioral Research. 

HI. Ext ra-Professional Control s . 

A • Instituti onal. Exampl e s : 

1. Setting credentials, policies, for hiring and promotion 

2. Administrative decisions on lines of research to engage in 

3. Budgetary allocations 
B. Legal . Examples: 

1. Professional licensure 

No such control for Ph.D. basic research and for many types 
of behavioral researchers/ therapi sts 

2. Licensure of research facilities 

3. Malpractice decisions, statutes 

4. Decisions, statutes on questions such as consent, proxy cense 
right to refuse treatment, definition of deat.n, privacy iig^ 
occupational health standards, etc. 


83 


5. Tort law 

C . State and Federal Legislative Acts . 

Establish regulatory agencies and their authority 

0 . Private and Governmental Funding Mechanisms , including: 

1. Universities and foundations 

2. Third-party payers: definitions of what is reimbursable 

re experimen ta 1 / therapeut ic status and re behavioral inter- 
ventions 

3. Agency (e.g. NIH, A DAM HA, NSFP, executive, and legislative 
policy decisions on appropriations for biobehavioral areas) 

4. Peer review processes for awarding funds 

5. Agency regulations, guidelines on conduct of research 

(a) with human subjects 

(b) basic research: recombinant DNA guidelines 

E - Agencies to Assess Appropriate U se. Assess Efficacy and Safety 
Examples: ' 

1. Regulatory agencies 

2. PSROs, HSAs 

3. GAO 

" The Publ ic . 11 Examples: 

1. Mass media 

2. Rel igious groups 

3. Special interest groups (e.g. voluntary health organizations) 

4. Public interest groups 



85 


Chapter 5 

Public Policies and Policy Mechanisms 

5.1: Introduction . 

Science and the Publ ic 

The conflict between academic research and public safety 
that has rocked Cambridge for the past three weeks marks 
a real and historically justified divergence. It is a 
conflict that has been intensified by the emergence, 
since the 1960s, of public participation as a functional 
tenet of democracy. And it took a major and, we think, 
good turn last Wednesday when the Cambridge City Council 
became the first local government in the country to in- 
tervene to limit scientific endeavors and showed it could 
balance the considerations fairly. 

As tiie Boston H obe editorial writer for July 10, 1976, points out, current 
public concerns about the needs and implications of biomedical and behavioral 
science and technology have two complementary aspects. On the one hand, each 
of the problems in question arises within a particular context, raises quite 
specific issues, and has an individual "bite": on the other hand, each of them 
is made more acute by the contemporary demand that there should be greater lay 
participation in all decisions materially affecting the public interest. As a 
result, even the most technical and technological looking problems often turn 
out to raise, also, important issues of social justice, public accountability, 
and political representation. 

In this report, we have set out to map some of the complex connections 
linking the biomedical and behavioral scientists' research laboratories to 
the social context within which health care is actually delivered. As we have 
seen, the lives and attitudes, health and sickness of the American population 
at large are affected by, and in turn affect the professional activities of 


86 


biobehavioral scientists and technologists in many varied ways. Scientific 
discoveries may have striking consequences for medical practice and the 
broader public welfare; but, just as often, changes in the broader pattern 
of social relations and expectations may create new opportunities for inno- 
vation in biobehavioral science and technology. When we address questions of 
public policy in the biobehavioral field, therefore the complexity of these 
interrelations is a prime consideration. 

In analysing and evaluating "the ethical, social, legal and public policy 
implications o^ biomedical and behavioral science, technology and services," 
we have been impressed by the multiplicity of decision points along the road 
between the research laboratory and the locus of health care delivery: i.e., 

the multiplicity of points at which policy options arise that can affect the 
country's "health system." At the scientific end of the spectrum, for in- 
stance, policy choices between alternative lines of biomedical and behavioral 
research can serve either to encourage or to counteract the current emphasis 
on the somatic determinants of health or ill-health, as contrasted with the 
environmental or social determinants, with all the practical consequences 
that flow from such an emphasis. At the consumer's end of the spectrum, other 
policy options can largely shape the manner in which, and the terms on which, 
the American public has genuine access to the great variety of health services 
theoretically available to them; and the varied patterns of health service 
delivery in other countries today clearly indicate that alternative policies 
could have resulted, and might yet result in this country too, in the develop* 
ment of a quite different pattern of relations between professional health 
care practitioners and their clients. (If Americans insisted on having 1 oca 1 f 


87 


controlled health centers as urgently as they insist on having locally con- 
trolled primary schools, the problems of creating such centers would be a 
matter not of technological ingenuity, but rather of political will.) 

Given the complexity of these interactions, it is a subtle and delicate 
task to establish and maintain a fruitful adaptation of Science to Society -- 
particularly, of biobehavioral technology to the nation's state of health. 

New problems are created in this area, not merely by changes in the content 
of biobehavioral technology, but also by changes in the context of health 
care, in the life habits of the public at large, and even in the basic structure 
of social relations; since changes on any of these levels can significantly modi- 
fy the legitimate needs or demands of the different agents involved -- whether 
scientists or technologists, physicians or administrators, politicians or lay 
people. 

In developing this present report, we have become especially conscious 
of eight general policy goals which seem most closely related to the "ethical, 
legal and social" problems of biobehavioral technology, and which are therefore 
in urgent need of attention. Three of these goals have to do with the roles 
of science and scientists in the process of biobehavioral innovation: 

(1) Reconsidering the priorities for scientific research 
in relation to biobehavioral technology; 

(2) Enlarging the scope for public accountability by the- 
scientific community; and 

(3) Developing new methods for assessing the social costs and 
benefits of biobehavioral technology. 


88 


Three of them have to do with the roles of biobehavioral technology in health 
care, and its relations to the administration and monitoring of health ser- 
vice del ivery: 

(4) Developing mechanisms for the evaluation of biomedical 
and behavioral therapies; 

(5) Improving social control over health costs and health 
service priorities; and 

(6) Increasing public participation in the local administration 
of health care. 

The two final goals are more general in their scope: 

(7) Redefining the scope of "expertise" in the areas of 
science, technology and health service; and 

(8) Developing mechanisms for the continued monitoring and 
evaluation of policy making in the biobehavioral field. 

All of these policy goals are directed toward what we see as Congress's 
continuing concern in this area, from the time of Senator Mondale's hearings 
until now. All of them (that is to say) are directed toward increasing the 
role of the larger community, of democratic procedures, and of broader public, 
interests, in channeling the application of biobehavioral technology to serve! 
the social and political ends of our society, without in the process stifling 
the professional enterprise of biobehavioral science itself. As a result, all 
of them are presented within the essentially pluralistic context of American 1 
society: with an eye to representing and harmonizing the distinct but legiti- 

mate interests of all the parties involved -- including the scientific re- 
search community, the professional providers of health care, ami the citizen- I 


89 


taxpayers who are also the final recipients (or "consumers") of health care 
services. 

We shall be discussing these eight sets of policy goals here in broad 
terms, and seeking to clarify the goals toward which they are directed. 

It does not seem to us that, in this field, one can formulate any general 
or universal "allocation principles," or develop any simple "algorithms" for 
deciding our policy problems; so we have concentrated rather on questions 
about the policy process, hoping to indicate some of the alternative means, 
or options, by which the goals might be achieved. Nor have we taken sides 
between the different options, or made any very specific proposals for re- 
form, since these would call, in each case, for more elaborate and sharply 
focused studies than we could embark on here. (The Commission may wish to 
sponsor sample studies of this kind at a later stage in its deliberations on 
the special study. ) 

5.2: Policy Goals for Biobehavioral Science and Technology . 

( 1 ) Reconsidering the pol icy mechanisms and priorities for scientific 
research in relation to biobehavioral technology . The current debate about 
the place of science and technology in contemporary society, and about the 
proper roles of the medical and scientific professions, has reav/akened ques- 
tions about the politics of scientific research -- notably, about the policy 
mechanisms by which research priorities are set -- that go back to the argu- 
ments about the social control of nuclear physics, and about the place of 
"basic science" on the national science, in the years immediately following 
World War II. This debate has once again called in question the standing of 
scientific research (including biomedical and behavioral research) as a 


90 


recipient of public support and finance; and it provides the occasion for a 
thorough reappraisal, not merely of the public administration of science, 
but above all of the manner in which research priorities are currently deter- 
mined and decided. 


The encouragement of responsible and wisely directed scientific research 
in the biobehavioral area is, of course, strongly in the public interest. If 
needless obstacles are placed in its way, the chief long-term victims will be, 
not the scientists themselves, but the entire community. In this respect, the 
implication of some current rhetoric about science -- that the public interest 
lies in protection from the activities of scientific researchers, rather than 
in the promot ion of their work -- must be heavily discounted. The central 
goal of policy for biobehavioral research should therefore be, not to hamper 
the progress of scientific research in general, but to insure that it is 
directed and conducted in fruitful, responsible and discriminating ways. 


While seeking to counteract any public "alienation" from the scientific 
enterprise, however, we equally need to ask ourselves whether, in the dacet 
mirations of research policy and priorities, scientists can hope to tc tain, i 
mini shed, the degree of autonomy to which they have become accustomed over the 
last 20 years. In this respect, it is important to see where the line must be 
drawn, between those narrowly technical choices which are most appropriately a 
efficiently made by the established process of professional "peer review," and 
those other broader questions about research priorities that inescapably raise 
social and political issues. Once a particular budget line has been establish 
to support research on (say) the molecular biochemistry of cell <ii/i , ■ , th 

further subdivision of those funds between the available "research projects 


91 


no doubt, in normal cases, be left to the professional judgment of the molecular 
biochemists and cell biologists themselves. Away from this purely technical 
level, quite different issues are involved. Decisions about the allocation of 
funds between work on different branches of science or types of diseases, or on 
disparate aspects of health and ill-health, take us into the realm of ethical, 
social and political considerations; and the full confidence of the public in 
the relevant processes of policy decision depends on its being clearly seen that 
the ethical, social and political interests of the wider community, in all 
their variety, are being adequately represented in those processes. 

Taken in its entirety, the problem of insuring that legitimate public 
interests are fully, broadly and fairly represented in the process of setting 
priorities for the public support of biobehavioral research, raises complex 
and varied issues. Different kinds of research involve different values; and, 
in each case, the most effective mechanism needs to be found for dealing with 
the resulting questions. As to the internal values of science: the questions 
that arise about the funding of the "purest" branches of basic science clearly 
differ from those about the funding of basic research that has evident prospect 
of practical relevance -- to say nothing about directly "applied" research in 
clinical medicine or elsewhere. (Research on physical cosmology, for instance, 
perhaps should compete for public support with symphony orchestras and art 
galleries, rather than with medical research.) As to the mechanisms of policy 
decision: the issues look quite different, depending on whether we see the 

central problem as that of insuring proper representation for t he public , or 
rather for public interests . In the determination of socially fruitful research 


priorities for applied science, the inclusion of "public representatives" on the 


92 


responsible committees and councils is only one -- and not necessarily the 
most effective -- possible means of getting "public interests" taken into 
account; and it needs to be considered just how the involvement of lay per- 
sons in the public direction of scientific research can contribute toward 
insuring that the "output mix" of biobehavioral ■ research serves the relevant 
lay interests in the most balanced manner. 

Two distinct sets of considerations are relevant at this point. On 
the one hand, there are grounds for putting a good deal of trust in the 
spontaneous decisions of the scientific research community, when those deci- 
sions are adequately informed about the actual needs of the larger society. 

In radar and medicine alike, for instance, the fruitfulness of wartime 
research during the early 1940s resulted less from any direct public parti- 
cipation in research decisions than from the scientists' own heightened 
awareness of the country's practical needs. (Often enough, indeed, the 
scientists' grasp of what was technically feasible made it possible for them 
to propose brand new lines of research, e.g., on microwave radar, that neither 
the public nor the military planners were in a position to foresee.) On the 
other hand, there are reasons for thinking that, at the present time, the de- 
cisions at which the scientific research community tends to arrive, when left 
to itself, are not adequately informed about broader social needs. The divi- 
sion of the overall NIH budget as between the different Institutes is deter- 
mined by negotiations within the NIH, and between NIH and the Congress, in whic 
different groups of research scientists press the technical claims of their 
various programs in the competition for appropriations . But it is not clear 
that, in the process, the scientists concerned either have, or seek out, any 


93 


real opportunity to assess the social significance of their work, or to 
measure the relative importance of their different programs against the 
evidence of wel 1 -documented public interests. (If it turned out -- to give 
just one example -- that malnutrition in our inner cities is responsible for 
serious neurological damage in the general population, are there any existing 
channels by which this knowledge would immediately influence -- or, better 
still, be sought out by -- the scientists at NIH working on neurological 
disease?) 

In thinking about the policy processes for determining research priorities 
in the biobehavioral sciences, accordingly, the Commission will need to discuss 
both how suitable individuals can be identified and recruited to serve as "pub- 
lic representatives" on the various public bodies involved, and also what other 
means exist of seeing that all relevant social needs and public interests are 
taken into account in shaping the research programs of NIH and other agencies 
responsible for directing and conducting biobehavioral research. These questions 
touch on the current structure and operations of NIH at more points and in more 
ways than we can discuss in detail here. In this respect, significant changes 
are in fact already under way within NIH, which -- if carried through -- would 
be useful steps in the directions we are proposing. For instance, there has 
been a first partial reorganization of the Director's advisory committee; there 
has been a broadening in the responsibilities of Study Sections, to embrace 
certain ethical issues (particularly, in the realm of "human subject protection") 
as well as technical matters; there has been a tentative move toward setting up 
new Study Sections for "sociomedical studies" and related fields, though this 
project apparently remains blocked within the upper reaches of the DHEW bureau- 
cracy; and there is a real prospect that creation of the proposed National Ethical 


94 


Advisory Board will make it possible for the NIH to move into the discussion 
of social, as well as more narrowly "ethical" issues. 

At some other levels, however, much could still be done. Though the 
Advisory Councils of the different National Institutes of Health could, in 
theory, serve as forums for the fruitful representation of public interests 
and needs, they are currently encouraged to do so only to a very limited 
extent, and the present methods of selecting "lay representatives" are open 
to question. (The public interest is not adequately served by the political 
appointment of busy celebrities like Mr. Frank Sinatra, however well inten- 
tioned they may be.) If the Commission wishes to pursue the problem of 
"public representation" further, indeed, one thing it may be helpful to 
evaluate is, just how representative and effective these Advisory Councils 
currently are, and how their operation can be improved. Meanwhile, some 
other major Federal agencies for the support of scientific research (e.g., 
the National Science Foundation) do not even have the full range of Study 
Sections and Advisory Councils existing at NIH; and, once again, the Commis- 
sion may find it desirable to evaluate the workings of those other agencies, 
before proposing the creation of any new institutions. 

Finally, there is the question of "community action" and "community repre- 
sentation" on a broader scale. The response of the Cambridge City Council to 
the problem of possible biohazards in Harvard's "Recombinant DNA" program is 
only one illustration of a more general issue. The task of promoting and chan- 
neling the vigorous and responsible development of scientific research, as an 
element in the national life, has to be dealt with at many levels and in many 
different places: not just in Washington or Bethesda but in states and local 


95 


communities across the country, not just on t he central budgetary level but 
at other more peripheral points, wherever significant decisions about science 
are taken. 

This need carries with it, also, an opportunity. If the political 
situation of America's scientists has weakened and eroded over the last 20 
years, one reason for this has been their unwillingness to spend time and 
energy seeking out and developing a sufficient constituency of sympathizers 
and supporters in the larger community. Nothing could do more toward over- 
coming this weakness than a readiness on the part of the scientific community 
in the United States to "open up" the argument about their own priorities and 
policy preferences to public view, and to draw in to the discussion a fresh 
population of informed arid interested laymen, who could develop into the sym- 
pathetic political constituency the American scientific community at present 
sorely lacks. 

( 2 ) Enlarging the scope for public accountability by the scientific 
community . To carry these issues one step further: the historical develop- 

ment of the natural sciences has reached a stage at which research scientists 
are having to accept a substantially higher degree of "public accountability" 
than they have been accustomed to up to now. In this respect, the recent 
move toward better protection of human research subjects is only one of several 
moves toward reintegrating the natural sciences into the wider community. For 
instance: whatever constitutional protection scientists might be able to esta- 

blish for their "freedom of inquiry" under the First Amendment -- an issue which 
has never been adjudicated in the Courts -- it is now, for the first time, an 
active and lively question whether the very pursuit of certain lines of research 


96 


may not expose the public at large to "clear and present dangers" whether in 
the form of radioactive contaminants or of "rogue" viruses. 

In this respect, without questioning the good will and hard work that 
went into the development of the NIH guidelines for recombinant DNA research, 
it is a real question whether enough was done to insure that the interests of 
the communities affected by the research were fully represented in the process: 
so, however adequate the actual content of the resulting guidelines may in 
fact be, there is no way in which, as matters stand, they can be generally 
perceived as being adequate. However exaggerated some of its rhetoric, the 
counterattack by the Cambridge City Council is a reminder that other consi- 
derations and parties are involved: neither on the national level, nor locally, 
do adequate forums apparently exist in which ethical, social and legal issues 
such as those raised by recombinant DNA research -- issues of kinds that are 
bound to arise again in the future in other cases, quite unpredictably -- can 
be argued out and resolved in ways that meet all legitimate concerns. 

The question of "public accountability" is, however, a broader one than 
this first glance at the DNA problem suggests. In considering how biobehavioral 
technology may affect their welfare or interests, the public at large are enti- 
tled to assurances of at least three different kinds. (1) They are entitled 
to protection against direct harm or injury from the acts of biobehavioral 
scientists and technologists, whether in the form of "biohazards" or otherwise; 
(2) they are entitled to be told, as early as possible, about any new tech- 
nologies that are coming onto the scene which may have major effects on their 
modes of life and/or on the structure of society; and (3) they are entitled to 
have their views taken into account, both about what things are currently going 


97 


amiss in the health care area, and also about what things they themselves see 
as constituting "good health," and so as the proper goals of health policy. 

Clearly enough, these three classes of "public interests" in the impli- 
cations of biobehavioral science and technology raise issues of quite dif- 
ferent kinds, and cannot all be dealt with by the same institutional mechanisms. 
Even the case of recombinant DNA is a complex one, and raises issues of all 
three sorts. For, quite aside from (1) the potential biohazards of the basic 
research itself, the longer term possibilities opened up by the developing 
techniques of "genetic engineering" both (2) stand to affect human life and 
society in some very profound ways, and in addition (3) would give us the 
means to perform all kinds of novel "corrective" and "augmentive" procedures, 
with major implications for our conceptions of "health" and/or "normality." 

The biohazards problem (1) is, of course, already being tackled by several 
government agencies, while the whole judicial system stands ready to intervene 
in case questions of tort liability arise about DMA research. Meanwhile, the 
questions raised by recombinant DNA research about (3) the nature of "health," 
and the development of new criteria of health, are just those that should be 
dealt with by the procedures discussed earlier, in connection with our first 
set of policy goals. There remains (2) the problem of developing a public 
"early warning" system: for drawing attention to radical new technologies, 

and provoking a public debate about their likely consequences for the general 
welfare and for the future of society. Here, the effective discussion is only 
beginning: the short term problem of biohazards has up to now largely dis- 

tracted attention from longer term questions about the practical applications 
that may flow from recombinant DNA research. 


98 


This, indeed, is one of the chief kinds of questions posed in the original 
Mondale Resolution, and we shall have more to say about it later on. For the 
moment, it is important simply to put on record the debt that is owed to the 
research scientists involved for, taking the initiative, and opening up the 
issues of recombinant DNA research at a time when the wider public had no reason 
to know what was on the way. The question is, how institutional arrangements 
can be developed, by which this individual initiative will become a matter of 
course, rather than a novelty or an exception: institutional arrangements (that 

is) by which scientific research workers will automatically accept and respect 
the need for public accountability, as a normal exercise in professional respon- 
sibil ity. 

In pursuing this policy goal, too, it is important that scientists should 
not see themselves as under attack, and so adopt a defensive posture. Since 
contemporary research involves possible hazards of quite novel kinds, scien- 
tists need to cooperate in working out procedures and mechanisms which fully 
satisfy all legitimate demands for public accountability, wherever there are 
genuine grounds for bringing scientific research under review. This need is 
not confined to individual scientific researchers. It applies, with still 
greater force, to the professional societies and institutions by which the 
interests of the scientific community are promoted and pursued. 

So, it does no good for such crucial organizations as the National Academy 
of Sciences to behave in ways that give the impression of "holding the public 
at bay." Nor does it help matters, either, for leading scientific agencies of 
the national government to define their functions in too narrowly technical a 
way, and shut their eyes to the social implications of their activities. A1 - 


99 


though "scientific autonomy" may be an effective organizing principle in 
the determination of research priorities, it is not in itself a value that 
can any longer be pursued without qualifications or exceptions. Rather than 
continuing to defend Science from outside criticism or regulation of any 
kind, the public spokesmen for Science would do better to help in devising 
methods of accountability that will leave the actual enterprise of Science 
as unhampered by regulatory processes as legitimate public needs permit. 

( 3 ) Developing new methods for assessing the soc ial "costs" and 
"benefits" of biobehavioral technology . Any proposal to introduce broader 
social considerations into the determination of public priorities -- whether 
for biobehavioral research or for the delivery of health care services -- pre- 
supposes that we have sufficiently precise ways of assessing "social costs" 
and "social benefits" in this area. At the present time, this is not the 
case, and we need to develop better "measures" or "indicators" for all the 
key variables, if we are to deal with the relevant social considerations in a 
subtle and discriminating way. Otherwise, there is a real danger that our 
political decisions will continue to be distorted by overreliance on exces- 
sively narrow economic definitions of the key terms involved. 

This general problem is familiar to those who have studied the problems 
of environmental protection: there the task of reanalyzing the "social costs" 

incurred through industry's uncontrolled and untaxed use of "the commons" -- 
air, surface water and the like -- has recently been receiving some overdue 
attention. But the same problems arise, with equal urgency, in the areas of 
health science and health care delivery. How are we best to interpret terms 
like cost and benefit , effectiveness and impact , assessment and accounting , as 


100 


they apply to innovations in biobehavioral science and technology, or to 
health service delivery systems? In such contexts, our "indicators" or 
"measures" will need to reflect the actual values, needs and preferences 
of the people affected in ways for which no clear "dollar cost" at present 
exi sts. 

In the industrial sphere, inadequately costed use of "the commons," 
resulting from reliance on misleading economic indicators for "business 
efficiency" and the like, played a substantial part in encouraging the in- 
efficient and polluting use of natural resources. In a similar way, a con- 
centration on limited, technical aspects of biobehavioral science and health 
service delivery, without any adequate costing of their other unintended 
prices and consequences, can have an equally misleading and distorting effect 
on health investment. In both cases, the problem is to make sure that cur 
reliance on current economic concepts and indicators does not distort the 
perception of our political aims: still more, that it does not guide us in 

directions which will actually frustrate the fulfillment of those aims. 

5.2: Policy Goals for Health Care . 

(4) Developing mechanisms for the evaluation of therapies . There is one 
other major area in which the public interest is at present particularly ill- 
served: viz., in the evaluation of medical, surgical and psychotherapeutic 

procedures, therapies and treatments. A full scale administrative mechanism 
exists, of course, for monitoring and regulating the development and intro- 
duction of new pharmaceutical preparations and devices, before they are put 
into general medical practice; and we have been very conscious, in our discus- 
sions, both of the positive services provided by such agencies as the Food and 


101 


Drug Administration, and of the criticisms to which their current structure 
and operations have recently been exposed. If we consider rather the broader 
field of medical, surgical and psychotherapeutic procedures, by contrast, the 
general public has at present no way of satisfying itself about the efficacy 
and merit of the treatments or therapies recommended to them by their pro- 
fessional advisors. And since, even in the pharmaceutical field, the effec- 
tive distance between the FDA and the actual recipients of health care is so 
vast, the lay public is too often confronted with a straight choice between 
following "expert" advice on trust, or walking out. 

Meanwhile, it is a commonplace in the world of professional medicine that 
the efficacy of many "routine and accepted practices" of long standing has 
never been subjected to full and detailed scientific evaluation by acceptable 
modern standards; to say nothing of some recent, fashionable surgical procedures, 
such as coronary bypass surgery. And, if this is true within the most narrowly 
technical of medical fields, it is certainly no less true in the burgeoning 
field of psychotherapy, "behavior therapies" and the like. 

In our meetings at Santa Fe and elsewhere, the possibility was much discussed 
of developing some kind of Therapeutics Evaluation Board, responsible for pro- 
moting and accrediting evaluations of medical and psychotherapeutic procedures 
of kinds that the public is currently compelled to accept on trust. The precise 
specifics of any such proposal would need very close examination. Some very dif- 
ferent patterns are clearly available: these could range from a publicly spon- 

sored advisory agency for "medical consumers," by way of a clinical research agency 
empowered to issue non-mandatory "certificates of efficacy," to a full scale regu- 
latory agency similar to the FDA, with elaborate mandatory powers. At the very 


102 


least, all authenticated information about the general efficacy, limitations 
and/or side effects of medical, surgical, psychotherapeutic and other health 
related procedures, should be readily available to "consumers" of health 
services, or their organizations. Since the aim of this proposal would be 
to bridge the gap between "experts" and the lay public, this kind of evalua- 
tion could not be left to an expert panel alone. Rather, what is needed is a 
"consumer oriented" agency, having not only the power to assess "efficacy" 
and "social costs," but also the prestige to influence the direction of re- 
search on new types of therapy and treatment modalities. This being so, the 
further problem arises of recognizing how research on new therapies and treat- 
ments (and the associated decisions about research priorities) are to be best 
related to biobehavioral research generally: particularly, that for which 

NIH is responsible. 

In this connection, the President's Biomedical Research Panel has urged 
that the research tasks and functions of the National Institutes of Health 
should be delimited narrowly: they have argued, for instance, that NIH 

should not be required to concern itself either with problems relating to 
health care delivery, or with questions about the efficacy of new therapeutic 
agents, treatment modalities, or programs of preventive medicine. Serious 
doubts have, however, been raised about these proposals. For it is not clear 
that the Panel's recommendations really confront the complexities of the 
choices involved, or do anything more than demand that the traditional auto- 
nomy of the biomedical research community be preserved in a rapidly changing 


situation. 


103 


Nor is there any obvious ground for consensus on the central issues of 
the Panel report. By now, both the Congress and the wider public are evi- 
dently coming to perceive the efficacy of medical and other health procedures 
as a matter of national responsibility: the kinds of programs of evaluation 

that are currently sponsored and/or mandated by the Food and Drug Administration 
in the case of pharmaceutical agents, and are being recommended by the Commission 
itself in the case of psychosurgery , will surely be extended, as a result, to 
other types of medical and surgical procedures, and to health care delivery sys- 
tems also. So, the question that needs asking is, not so much how N1H can be 
spared from involvement in these further responsibilities, as how these new 
tasks are to be most effectively related to Kill's central responsibilities for 
basic science. 

If the problem is restated in this way, the choice it calls for is not 
easy. Whether the duties of NIH are enlarged to include therapy evaluation, or 
whether some other research agency is created for that purpose, cifficulties will 
created for the biomedical research community in either case. On the one hand, i 
is the received wisdom -- as expressed in "Shannon's Law" -- that any involvement 
of NIH in matters of health care and health service delivery only dilutes the 
quality of its scientific work. On the other hand, while NIH at present has 
the capacity to attract the best scientific manpower in the biomedical field, 
any policy that resulted in a diversion of public funds into a competing re- 
search agency for clinical evaluation and research might, in the longer run, 
pose a more serious danger to the scientific supremacy of NIH. 

(5) Increasing social control of health costs and prioritie s. The develop- 
ment of biobehavioral technology has social and political implications for health 


104 


care in the area of health service costs and priorities also. For the most 
part, we have avoided concentrating on the specifically economic aspects of 
health care delivery and related services in our discussions. We have done 
so, not because we consider economic issues unimportant, but rather because 
most of the technical questions about health care costs, resource allocation 
and the like, seemed to us to be properly statable and answerable only when 
viewed against the background of larger social and political issues and 
pol icies. 

In studying the changing scope of biomedical and behavioral practice, 
for instance, we repeatedly noticed how prior commitment to a particular pat- 
tern of health care services can influence the professional values of the prac- 
titioners involved -- whether physicians, medical administrators, or whatever; 
and this commitment may, as a result, dictate a particular kind of reliance 
on new (and often very costly) technological apparatus. To cite one extreme 
example: the determination to keep terminally ill human beings alive at any 

cost, even in a vegetative state -- whether that decision rested finally on the 
most admirable ethical principles, or the fear of litigation -- would involve 
the health service system in a vast investment in expensive machinery for "pre- 
serving life" (or "prolonging dying") to the detriment of other kinds of health 
care. In less obvious ways, likewise, any preoccupation with the somatic dete 1 ' 
minants of health and ill-health, or neglect of the social and environmental 
determinants also encourages physicians and administrators to invest in "tech- 
nological fixes" which may, by epidemiological standards, be more expensive 
than they are effective. 


105 


In the long run, it is hard to see how the problem of health service 
costs and priorities can be dealt with, without bringing them under more 
direct social control. At earlier stages in the development of modern medi- 
cine, it may have been legitimate to regard the practical problems of health 
care as "technical" problems for the medical profession and its immediate 
associates. In the future, this view will surely be less and less acceptable: 
both, because the actual content of health care problems increasingly involves 
ethical and social, as well as technical issues, and also because so large a 
fraction of the costs of the health care system are being paid out of tax money. 
From now on, it will be necessary (as Lewis Thomas argued) to justify all ela- 
borate investments in "high, technology" equipment in terms of a broader system 
of social values and priorities; and policies which encourage such investments 
will have to be decided on quite deliberately, and defended, in relation to 
that broader scheme of social priorities -- in competition with (e.g.) anti- 
pollution measures, new employment policies, policies for nutrition, and the 
rest. That being so, it should be clear that all such decisions finally rest 
on a pol i tical basis, and that the entire American electorate has a legitimate 
stake both in the procedures by which the decisions are made, and in the steps 
that are taken to monitor and control their consequences. 

(6) Increasing public involvement in the local administration of health 
care . The changes outlined in the first chapter of this report, in the social 
context of health care and in the very concept of "health" itself, have signi- 
ficant implications for the control of health care administration at the point 
of delivery. As matters stand, health care professionals -- physicians, psy- 
chiatrists, surgeons, etc. -- retain a substantial monopolistic control over 


106 


the actual provision of services to the client or consumer. As a result, 
patients often find it hard to be confident that the services actually pro- 
vided take sufficient account of their own social situations, ethical beliefs 
and patterns of life. Rather, the professional inclination to "tunnel vision" 
caricatured many years ago in Bernard Shaw's play, The Doctor's Dilemma , is 
growing stronger not weaker: being reinforced by (for instance) the need to 

select technical procedures of kinds that are "reimbursable" from medical 
insurance. 

This "over technicization" of health care delivery can probably be over- 
come, only if the recipients of health care are involved to a much greater ex- 
tent in its organization and administration, and if those services are oriented 
towards the specific needs and problems of particular communities, work places, 
etc. Such an orientation would naturally help the health professionals involved 
to focus on those elements of the social context that may be as essential for 
the delivery of full health care as the more narrowly technical factors. And, 
further, such a reorientation might well make it possible to provide health 
services that were not only more relevant to the patients' actual situation, 
but are also more economical. 

In our discussion, we heard reports about "health service units" or "group 
practices" in which the organization and administration are run jointly by 
the professionals and the lay public involved; and these reports suggested that 
an open collaboration can be of immediate benefit not only to the public, but 
also to the professionals themselves. So long as the providers of health care 
are tempted to set themselves apart from (even, above) their clients and 
patients, they only encourage exaggerated expectations on the part of the lay 


107 


public, which subsequently give way to disillusion at the lack of success, 
and may eventually result in litigation. When they approach their patients, 
instead, as colleagues rather than expensive benefactors -- not to say, 
miracle workers -- they can reasonably hope to develop a better understanding 
about the actual needs of these patients, and so win back some of the confi- 
dence and respect that has been eroded over the last 10 or 20 years. 

In this respect, the professional providers of health care -- like the 
scientific community can well afford not just to "mend their fences" with 
the larger public, but to encourage the development among the lay public of 
the capacity for knowledgeable involvement in health related matters. 

In this respect, the new "health systems agencies" provided for in P.L. 
93-641 could create a fresh opportunity for involving the lay public in the 
monitoring and administration of health service delivery at the regional and 
local level. If experience with the recently established PSROs provides any 
guide, one cannot be wholly sanguine that this will in fact happen. Although 
the PSROs too are supposed to operate "in the public interest," it is already 
apparent that they can easily be "taken over" and run by the professional guild 
of health service providers in their own interests; and there is a danger that 
citizen participation in both PSROs and HSAs will -- aside from a little popu- 
list rhetoric -- be neutralized, if not toally frustrated. The secrecy with 
which some PSROs have begun to operate can serve only to protect the interests 
of the professional guild from public scrutiny not to promote the delivery of 
better service t£ the public. (Why should the public not be allowed to find 
out how different hospitals and/or physicians are evaluated by their colleagues? 
Why should not PSRO assessments, either of individuals or of institutions, be 


108 


public documents?) The institutions of government in a democracy are pro- 
perly directed, not to entrenching monopolistic practices still further, but 
to defending the larger interests of the consumer against the abuses of mono- 
poly power, whether by industrial corporations or by "learned professions." 
Indeed: one very helpful task the Commission might choose to undertake is 

that of evaluating the operation of PSROs and other novel institutions for 
monitoring the quality of health care. 

5.4: Other More General Policy Goal s. 

(7) Redefining the sc o pe of "expertise . 11 The general thrust of our pre- 
sent argument is not to call in question the need for professional expertise 
in the fields of health science and health service delivery. On the contrary: 
there is clearly a need to develop and maintain technical facilities and skills 
of the highest quality, as one important resource within the entire health 
service system. Instead of denying the claims of professionalism, we would 
argue that the benefits of expertise should be more widely shared, and that in- 
stitutional obstacles to the fruitful collaboration of professionals and the 
lay public should be further lowered. It should be one goal of policy, accordr 
to scrutinize and redefine the scope of expertise in the biobehavioral field an: 
to modify the legal and institutional framework of health care so as to meet 
the actual needs of a rapidly changing situation. 

So long as the actual content of medical and psychiatric knov/ledge remainec 
intrinsically scientific and technical, as it was during the post-Flexner era, 
the technical concerns of health care professionals were -- understandably, eve' 
if never wholly justifiably -- rather sharply separated from the human concerns 
of the lay public. Given the current broadening in the scope of health needs 


109 


and health services, by contrast, there are strong arguments for allowing 
broader access to the specialized knowledge which has, during recent decades, 
become the private preserve of the medical and health related professions. 

Just as, within future health care systems, the values determining the "appro- 
priate" use of new biobehavioral technologies will have to be public values, 
rather than technical or professional ones, so too the skills and knowledge 
mobilized in the course of health care could with advantage be spread more 
widely. 

In certain respects, the technicalities of physiology or psychiatry will 
no doubt remain matters for specialists; yet that is no reason for making the 
entire body of medical understanding an arcane mystery, or for preserving rigid 
professional boundaries in the face of broader social needs and priorities. On 
the contrary: one practical step toward "defusing" current problems in the 

health service system would be to give better statutory protection to the work 
of (e.g.) paramedical personnel, "self-help groups," community referral centers, 
and similar joint lay professional initiatives. For complex reasons of history 
and law, the provision of psychotherapy and other behavioral services has never 
become so restrictively organized as is the case in medicine proper. Rightly 
or wrongly, it has been assumed that patients are less gravely "at risk" in 
their dealings with psychological counsellors than with physicians and surgeons. 
Within the behavioral or psychological field, in consequence, there is at present 
much more scope for "therapy groups" and the like, than there is for (say) giving 
real medical responsibilities to nurse practitioners, or paramedical personnel. 

Without questioning the need for responsible supervision by fully qualified 
practitioners, one may still see strong arauments for the often-expressed view 


no 


that many medical practitioners are currently "over-qualified" for their actual 
work; so that the delivery of health care to those in need could be organized 
more economically, as well as more effectively, and in ways more directed toward 
their actual situations and values, if a much larger segment of the population 
had access to medical and other health related knowledge. In both the health 
sciences and the health care delivery system, a lowering of the barriers between 
health professionals and the larger public would encourage a broader under- 
standing, both of the proper requirements of "technical expertise," and of the 
necessary social goals and priorities of an effective health service. 

( 8 ) Mo n 1 1 oring and evaluating policy making institutions and mechani sms 
in the h ealth field . In conclusion, let us draw attention to one special pro- 
blem, which arises directly from the complexity of the interactions between 
modern biobehavioral technology and the larger activities of American society. 
As matters stand, it is almost impossible for any one person to recognize all 
the different "decision points" along the road linking health science research 
to the actual provision of health services: still less, to obtain a proper 

overview of the effects of the decisions taken at all these different loci, or 
put forward a rationally based policy for coordinating the decisions taken at 
all these different points. So, quite apart from all questions about reforming 
existing institutions or creating new ones (e.g. for therapy evaluation), it 
should be a central goal of policy to improve our means for monitoring and 
evaluating the whole range of policy making institutions and mechanisms in the 
health field. 

At this point, the Commission might well consider undertaking, or sponsorir; 
some further studies, aimed at spelling out the nature, functions and techniques 


Ill 


of "evaluation" and "monitoring" in this field. Over the last 35 years and 
more, a powerful methodology has evolved for evaluating drugs, therapies, etc. 
by the use of "double blinds," placebos and the rest; while some kind of a 
beginning has been made with techniques of "program evaluation" in connection 
with Head Start and similar 0E0 programs. But, hitherto, we have had no 
general technique for evaluating the operation of entire social agencies or 
institutions. In this respect, indeed, the Commission's own investigations 
into the operation of Institutional Review Boards represent a significant 
innovation in the techniques of social evaluation. If the aims of the pre- 
sent special study are to be carried through further, one way of proceeding 
may thus be to identify some of the key social mechanisms involved in the 
health science and health care systems, and to extend to them also the kinds 
of scrutiny already given to IRBs. The first step toward an effective policy 
for the social application of biobehavioral technology must, after all, be to 
develop better methods for identifying and monitoring the operations of the 
different aspects and agencies involved in the development and utilization 
of that technology. 

l.e recognize that some important steps have already been taken in this 
general direction, in recent months and years. An Office of Science and Tech- 
nology Policy is being reinstated in the White House, under a President's Science 
Advisor; the Office of Technology Assessment has been established in the Congress 
while the Institute of Medicine of the National Academy of Sciences undertakes 
important studies on the economic and social aspects of health science and 
health care; not to mention the creation of the National Commission for the Pro- 
tection of Human Subjects- itself. In addition, the General Accounting Office 


112 


retains its own power to step in and conduct detailed evaluations of public 
programs, as occasion requires, in the health sector as in any other. r\l 1 
the same: it is not clear, as things stand, that the operations of these 

agencies will have the continuity needed if the operations of the policy 
mechanisms intervening along the way between the scientific laboratory dnd the 
point of health care delivery are to be adequately monitored. So, there still 
seem to be strong arguments in favor of establishing just the kind of "National 
Advisory Commission on Health Science and Society" contemplated in Senator 
Mondale's original resolution of March, 1973. As we see it, such a National 
Advisory Commission would need the same kind of broadly representative Member- 
ship as the existing National Commission for the Protection of Human Subjects. 
It should include people with a wide range of humanistic or social qualifica- 
tions, as well as health professionals; and it would require substantial auto- 
nomy and independence from the Executive departments. Whether it might operate 
alongside, or under the wing of the present Commission, or in conjunction with 
the OTA or some other Congressional agency, is a matter for subsequent deuate 
on which we shall give no opinion hoe. 

One last point we do have to add, by way of conclusion. The ethical, soci 
legal and public policy problems connected with biobehavioral technology have 
arisen, and will continue to arise, in largely unpredictable, ways. Although 
Section 203 of its establishing Act instructed the national Commission to units 
take a "comprehensive study" of these implications, that task cannot he tackle 
and completed exhaustively, and once for all. Instead, the prchle s aris me * 
this area need to be kept under continuing scrutiny and review; and, wVwmi 
else comes out of the present special study, we particularly hope that Congrcs 
will recognize the desirability of such continuing evaluation. For the t ■ ,i 


113 


laid out in Section 203 will have to be tackled afresh, repeatedly and in new 
contexts, in the light of future technological innovations whose nature and 
social implications cannot at present be foreseen; and also with an eye to 
future changes in the broader economic and social, political and cultural 
situations. 


Report edited by Stephen Toulmin 
(University of Chicago) 

Staff Member, Philosophy 


115 


APPENDIX 1 

The Case of Hypertension 
by Eric J. Cassell , M.D. 

The case of hypertension is useful in a discussion about the protection 
of human subjects because of the many ways in which the disease can be seen 
and the changes in the meaning of "human subject" that occur with these different 
frames of reference. 

Hypertension is a disease in the most classic sense. This is to say 
that* even before the existence of practical devices to measure blood pressure, 
the disease was (or could have been) known by characteristic changes in the 
heart, kidneys, and other organs. The heart, seen simply as a mechanical pump, 
changes size and configuration as a result of prolonged pumping against an 
increased load. Persisting long enough, this extra work leads to failure of 
the heart to meet the load and congestive heart failure results. Characteris- 
tic changes in the small blood vessels results in renal disease and ultimately 
renal failure. Other blood vessel effects are seen in the heart and brain. 
These alterations are associated with the stigmata of long term hypertension - 
heart failure, myocardial infarction, renal failure and stroke. As I noted 
earlier, this pathology, particularly the heart and renal failure, can be 
identified without reference to a measure of blood pressure and meets classi- 
cal structural criteria for the definition of a disease. This one view of 
the human subject with hypertension falls within the framework of the classical 
medical model - the person with abnormal organs whom we term diseased. We are 
not used to calling such people human subjects but rather prefer to call them 
patients." They are the object of our care because they are sick by any 


116 


definition (and probably in any culture). Their protection involves protection 
from their illness - the agent of damage is their disease. They and our society 
believe their protectors to be physicians. 

It came to be known, ho wever, that the damaged organs of such people v . js 
associated with elevated arterial blood pressure - the state called hypertension. 
Hypertension is now defined as a blood pressure of greater than 140 mm of mercury 
systolic and 90 mm of mercury diastolic. It should be recognized that the defi- 
nition is somewhat arbitrary. Normal blood pressure ranges from over 200/100 
(with vigorous activity) to very low pressures during sleep. But physicians 
have defined hypertension as a blood pressure of over 140/90 whenever taken at 
rest in a medical setting. Physicians are primarily interested in fixed hyper- 
tension - when the blood pressure is always greater than 140/90 taken at rest. 
(Blood pressure varying from high to low in that setting is called labile hyper- 
tension and is presently of lesser interest.) It is of some interest that recerr 

studies have shown that the blood pressure taken in the doctor's office is an 

accurate reflection of the blood pressure throughout the day. 

There are a few known causes of hypertension. Certain tumors o: the 
adrenal gland and a type of alteration in blood flow to the kidney, for example, 

are causes, but in the vast majority with high blood pressure, no cause can be 

found. These individuals are said to have essential hypertension. Lack of 
demonstrable cause has allowed theories of cause to proliferate - and ir,de«dB 
they have. Excess dietary salt, repressed rage, urbanization and other possl 
bilities have all been offered with, unfortunately, a dearth of sup;crtv.v 


dence. 


117 


What is of greater importance is that the state of hypertension has come 
to stand for the disease hypertension. By that I mean that, in the minds of 
laymen and even many physicians, the state of having elevated blood pressure 
has c one to be equated with the disease characterized by alterations in blood 
vessels and the heart that I discussed above. In the simplest terms, many 
people with high blood pressure feel themselves to be in imminent danger of 
having a stroke even when their hypertension is first diagnosed. In fact, sus- 
tained elevation of blood pressure is a risk factor causally related to the 
disease but the relationship is not one-to-one. That is, not everybody with 
high blood pressure develops the disease and at this time, there is no way of 
predicting who will and who will not develop heart failure, heart attacks, renal 
disease or stroke. Further, the condition of having fixed elevation of blood 
pressure (ever l‘.0/50) has no symptoms, despite the fact that patients often 
attribute their headaches or their lack of feeling fit to their elevated blood 
pressure. Recent studies have shown that hypertension is an extremely common 
condition in the United States. Somewhere between 10" and 20' of the popula- 
tion has elevated blood pressure. Ethnic differences in the prevalence of 
hypertension have been known for many years. Recent studies show that 71% of 
black women over 65 years of age have hypertension as compared to 49% of white 
women of the same age. In the same age group, hypertension occurs in 66% of 
black males but only 27 of white males. For people over age 18 (hypertension 
is rare below that age), the prevalence among blacks is 28% and among whites 
15%. 


Effective measures for lowering blood pressure have been available for 
many years, but until relatively recently, most such drugs had serious or very 


118 


unpleasant side effects. That may have been one of the reasons that contro- 
versy over the utility of lowering blood pressure to prevent the effects of 
hypertension has also raged for years. But, more recently, carerully controlled 
large scale clinical studies have demonstrated clearly that sustained lowering 
of blood pressure is both possible and beneficial. This is to say that a popu- 
lation of hypertensive people whose blood pressure is maintained by medication 
at normal or near normal levels does not develop heart disease, stroke 01 ' enal 
disease with anywhere near the same frequency as a population whose pressut e 
remains elevated. Furthermore, blood pressure can be lowered in 85% of hyper- 
tensives by the use of one drug from the class of thiazide diuretics. These 
agents contract the body's fluid volume by depleting sodium (many patients 
call them "water pills"). Thiazide diuretics have a low (though not negligible) 
incidence of side effects and often one pill daily is sufficient. The blood 
pressure of most of the other 15% can also be lowered although the use of other 
drugs increases the complexity of treatment and the incidence of side effects. 

I can summarize at this point by saying that hypertension has now become,, 
in the minds of the public and many physicians, not the disease of heart blood 
vessels I described originally, but rather a disease characterized solely by 
the numbers that come from a blood pressure instrument and the threat of heart 
disease, renal disease and stroke. Further, hypertension is extremely ccmonl 
and shows ethnic differences in prevalence which have political overtones. 
Finally, the disease is easy to treat and treatment is effective in reducing* 

ri sk. 

One might say, as many have, that hypertension represents the ideal easel 
for preventive medicine. By the application of relatively simple therapy to I 


119 


large populations at risk, the risk is abated. Indeed, the argument has been 
extended by the demonstration that the children of hypertensive parents have 
higher blood pressures (although within the normal range) than the children of 
non-hypertensives and that therefore treatment should or at least could be 
started in childhood. 

It will be apparent on a few moments reflection that it is not practical 
(or perhaps even possible) in doctors' offices or hospitals to find and treat 
the between 20 million and 40 million people in the United States who have high 
blood pressure. 

Popular expression of the need to find hypertension are the high blood 
pressure booths that can be found in churches, supermarkets , health fairs and 
so forth . Recent excellent research has shown the practicality of diagnosing 
and treating hypertension on the job site using paramedical personnel trained 
specifically for this. The. ubiquitous blood pressure instrument and the sim- 
plicity of treatment make these massive efforts possible. It has also been 
demonstrated that job site non-doctor treatment may be more effective in main- 
taining lowered blood pressure than therapy given by physicians in their offices. 

Who is now the human subject? It is no longer someone with damaged organs 
who must be protected or saved from that damage. Rather, the human subject is 
a person with elevated blood pressure and no evidence of disease but a subject 
merely because he has a risk for a disease. And we do not know how great 
the risk is! In the enthusiasm for widespread treatment (on the job, in the 
community but not necessarily in the doctor's office), two important facts 
have dropped from sight. The first is that of a group of individuals found 


120 


to have elevated blood pressure about one third will be shown to have normal 
blood pressure on repeated measurements. The second commonly overlooked fact 
is that the Veterans Administration's study which demonstrated the utility of 
lowering blood pressure to prevent heart disease and strokes only included 
patients whose diastolic blood pressure was over 1051 

Therefore, it is not at all clear what overall benefit will come from 
treating huge numbers of people with elevated blood pressure. Some indivi- 
duals will be prevented from developing hypertensive disease but no one knows 
who those individuals are. While hypertension is very common, death from 
hypertension (or associated diseases) is vastly less common. At present, it 
is impossible to predict which person with elevated blood pressure will go on 
to develop hypertensive disease. Thus, the benefit of mass treatment is un- 
clear. What, aside from money and manpower, are the costs? 

Although the thiazide diuretics presently used to treat hypertension 
appear to be relatively safe, they do have side effects. What will be the 
effect of treating a huge number of people with a drug that depletes the body] 
of sodium and potassium, that produces varying degrees of impotence in as 
many as 25% of males, and that occasionally produces depression or other 
psychic symptoms? 

The answer is not known because the drugs have not been used long enough, 
but it would be extremely unusual if this was the first drug not to have unin- 
tended long term problems. 

Other things need to be considered. What will be the effect oi cnnvinc® 
millions of people that they have a disease (and they must be convin • ! or thl 


121 


will not take the medication) when, in fact, they may not? The treatment 
of hypertension in churches and on the job does not demedicalize hypertension , 
rather it increasingly medical izes a large population that may already be too 
medical ly minded. 

In other words, the worst unintended side effect of the mass treatment of 
hypertension may not be the production of deleterious drug effects but rather 
the solidification of a wrong framework of reference. The reason mass therapy 
of hypertension seems so reasonable is the exclusive focus on the possibility 
of heart disease or stroke. Another example may make the point. A patient 
had a lump in her thyroid which was thought at first to be an unimportant 
cyst. A new diagnostic method was used which raised the question of solid 
tumor and, by inference, of cancer. Imiediate operation was advised. It was 
not a big operation, but she was in considerable discomfort for about two weeks. 
The scar will be on her throat forever, and she will dress differently because 
of it for years. The tumor was benign. Discussions of tumors of the thyroid 
always focus on the question of malignancy and outcomes are measured in those 
terms. We do not discuss outcomes in terms of peoples' lives but only in terms 
of the tumor. Was the tumor car.cer and what happened to the tumor? That may 
seem reasonable at first thought; after all, if someone has lung cancer, the 
tumor's fate is their fate. But it is not so reasonable even when death is the 
inevitable result because, as we have come to learn, there is more than one 
path to death. And when death is not the inevitable issue, such a focus or 
framework of reference is even less reasonable. While cancer of the thyroid 
is not rare, death from cancer of the thyroid is very rare. Should we not ask 
other questions apart from whether or not somebody is going to die? It seems 


122 


to me that it is reasonable to widen the framework of reference. Do people 
who are operated versus those who are not have more divorces, poorer work his 
tories, less or more children, more frequent other illnesses or operations 
and so forth? Is not the fact that families of leukemic children have very 
high breakdown and divorce rates part of the outcome of leukemia? 

If these wider frames of reference are important in considering malig- 
nancies and their treatment, they should be of even greater importance in con 
sidering the protection of human subjects who are found to have an elevated 
blood pressure. 

In looking for unintended side effects of the mass treatment of hyperten 
sion, we must look beyond the side effects of the drugs. What happens to the 
lives of people involved in treatment programs and to their other health re- 
lated behavior? 

It is difficult to focus on these other questions precisely because we 
have always seen our job to be epitomized by the protection of hypertensives 
from stroke. It is reasonable to ask what the price will be for the whole 
population if mass treatment programs for hypertension continue to hold us 
to such a narrow view of human existence. 


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APPENDIX 2 

Menta l Health and Beh av ior C on trol 
By Gerald L. Klerman and Perry London 

I . Introduction: O v erv i ew of Future Trends 

Psychoactive drugs and diverse forms of behavior modification and psycho- 
therapy are the two major technologies developing in the mental health field. 
The use of both of these technologies is increasing enormously, and will 
likely continue to increase in the foreseeable future. This paper will des- 
cribe the background of these events and examine some of their social impact. 
Our general forecast is that the future belongs to mental health (or to mental 
illness, depending on how one looks at it). Within this general forecast 
statement, we will discuss four topics: 

(1) The increase in use, now and in the future, of drug and 
behavioral technologies in mental health services. 

(2) Their impact on the organization of the mental health care 
system and therapeutic practices. 

(3) Areas of public policy concern, particul arly : 

(a) behavior control as a possible political danger, and, 

(b) the boundaries of health and problems of living and of 
values. 

(4) Possible public policy mechanisms to enhance or constrain 
control or development of these trends. 

I I . The Two Technologies 


There are two technologies in mental health now developing very rapidly - 


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psychoactive drugs and behavior modification and psychotherapies. In various 
forms, they have been with us for many decades, if not centuries. What is new 
is the growth in their complexity, technical sophistication and scientific 
foundations in experimental psychology, neurochemistry and pharmacology. Like 
all technologies, the degree of benefit or harm attendant to their use depends 
not so much on their intrinsic scientific basis or empirical technique, but 
upon the social values and public institutions brought to bear to channel, 
encourage, regulate or control their development and application. 

Because of the potential of this technology, the title of this paper in- 
corporates two of the alternative uses of drugs and psychotherapy. The two 
technologies to be discussed - psychoactive drugs and behavior modification 
and psychotherapy - can be utilized for therapeutic purposes in mental healtn, 
or for behavior control. To what extent they will be so utilized in the future 
will depend upon our society's values, and the public policy mechanisms imple- 
mented . 

New Drug Technologies 

In the past two decades, there has been an explosion of interest and know- 
ledge and use of drugs for behavior. The psychoactive drugs are of increasing! 
number and kinds. The history of the development of these drugs is well des- 1 
cribed (Swazey, 1974) (Ayd, 1972) (Caldwell, 1970). (Swazey's book provides 
an excellent history of chlorpromazine, the first phenothiazine) . 

In Brave New World Revisited , Huxley cites with horror the fact that, in I 
the U.S. alone, 48 million prescriptions a year were being written for tran- 
quilizers. That was in 1958. Six years later, over 45 million prescriptions j 


125 


were written for the three major tranquilizers alone, and another 104 million 
prescriptions for other psychotropic drugs. This phenomenal increase in the 
number of such drugs around and the extent to which they are being used has 
been continuous over the past two decades, with the total number of prescrip- 
tions for them, by now, on the order of 270 million annually, which is per- 
haps 25« of all the prescriptions being filled in American drugstores. Also, 
new drugs, such as the antianxiety and antidepressant drugs, tend continually 
to replace older ones, such as the barbiturates, but not to replace them com- 
pletely - so the whole armory grows in variety as well as size. 

Concern over psychotropic drugs is among the oldest end newest of civi- 
lization's preoccupations. At the dawn of civilization, in the Ancient Middle 
East, alcoholic ferments were widely utilized, having been developed at about 
the same time as the domestication of animals, the discovery of agriculture, 
and the creation of the first cities. Almost every society since has developed 
various potents, brews, and remedies aimed at changing mood and behavior, be 
it disturbed or normal. The ancient Greek Homeric legends contain discussions 
of various drugs which today we would consider psychotropic . In western society, 
scientific interest in psychotropic drugs emerged in the middle of the nineteenth 
century when pharmacology and psychology developed as distinctive scientific dis- 
ciplines. In France, Austria, England, and the U.S.A., interest grew in the op- 
iates, in hashish, and in other derivatives of cannabis, and in cocaine, as 
Western European scientific and intellectual circles became increasingly aware 
of drugs used for psychotropic purposes in the cultures of South America, the 
Middle East, and the Orient. 


126 


Psychopharmacology did not emerge as a distinct science, however, until 
the decade after World War II. The term psychopharmacol ogy had been used in 
the 1940s and 1950s in a few scientific articles, but it was not until the 
discovery of LSD by Hoffman in 1943 and the synthesis and clinical introduc- 
tion of chlorpromazine by French pharmacologists that a systematic, scientific 
investigation of drugs which affect the mind reached self-conscious and organized 
proportions. Thereafter, the pace quickened rapidly. Dozens of new compounds 
were developed for therapeutic investigational use, various national and inter- 
national societies were formed, and federal and other support emerged. 

In large part, the rapid growth and wide impact are consequences of the 
recent development of pharmacologic compounds which alter mental functioning 
and of the reevaluation of previously used substances such as alcohol and canna- 
bis in the light of advanced psychopharmacol ogic techniques. The findings from 
neurobiology, neurochemistry, and neurophysiology have also made it increasingly 
possible to relate the psychological effects of psychotropic drugs with nor al 
biological mechanisms of action upon the brain. 

Today, the science of psychopharmacol ogy encompasses the study of a wide 
range of compounds, only some of which are being used for therapeutic purposes. 
Psychopharmacol ogy refers to the scientific field which studies drugs that 
affect the mind, behavior, intellectual functions, and mood. Psychotropic 
drugs are those compounds which influence the psychic functions and behavior. 

Not all psychotropic drugs are therapeutic. For example, heroin, LTD and 
alcohol are psychotropic drugs with considerable social and research interest, I 
but currently they have no demonstrated therapeutic value in the treat ent of 
established mental illness. Reevaluating previously used cempoun !s in light of 


127 


new discoveries of the relationship between the brain and behavior, it is 
possible to regard psychotropic drugs as falling into three main groups 
depending on the purpose for which the drug is used. These groups are: 

1. Therapeutic agents . Those psychotropic drugs such as antipsy- 
chotic, antidepressant, antianxiety agents used for treatment of 
psychiatric disorders. The success of these compounds has contri- 
buted greatly to the changes in the therapy of mental illness and 
to man's greater awareness of the potentialities of psychopharmaco- 
logy. 

2. Drugs used for nontherapeutic pur poses - recreation or personal 
enjoyment. It is indicative of the ambivalence of our society towards 
these compounds that no generally agreed upon term exists for this use 
of psychotropic drugs. Included in this group are alcohol, hashish, 
marijuana, and other derivatives of cannabis, the various hallucino- 
gens (also called psychomimetics) and psychedelics, including LSD, 
psilocybin, and mescaline, and the various opiates including morphine 
and heroin. These drugs have in common the capacity to alter the nor- 
mal mood state in a way that subjects find pleasurable and seek re- 
peated experience without being directly involved in treatment of de- 
fined mental illness or psychological disturbances. 

3. Drugs to enhance performance and capabilities . Although, at the 
present time, there are relatively few drugs which have the demonstrated 
capacity to enhance performance, this area probably represents the future 
scope of psychotropic drugs. Currently, drugs such as caffeine, and at 
times amphetamines, are used to counter fatigue and to alter the decrement 


128 


of performance by improving memory, learning, sexual ability, and 
intellectual functioning. Use of these drugs generates controversy 
and conflict in society, since we have not yet determined the modes 
by which individuals and groups should regulate and control conscious- 
ness, emotional states, or behavior by use of psychotropic drugs. 

Psychoactive Drugs Used as Therapeutic Agents 

The treatment of mental illness has been dramatically changed, if not 
revolutionized, since the mid-1950s, when pharmacotherapeutic agents had 
their first impact. During a brief period, four new types of drugs were intro- 
duced into therapeutic practice: chlorpromazine, rauwolfia, meprobamate, and 

imipramine. The dramatic effects of these drugs on a wide variety of mental 
and ocher illnesses not only has influenced therapeutic practice, but also 
has led to increasing sophistication in the evaluation of these compounds. 
Because, of initial skepticism about their efficacy, considerable effort was 
expended to develop new research techniques, and new methods evolved such as 
the double blind and placebo-controlled trials, advanced descriptive techniques 
psychometric evaluation, and multivariate statistical techniques dependent upon 
computer technologies in the evaluations. As a further consequence, the demon- 
strations of the therapeutic efficacy of these compounds generated questions 
about their modes of action on the brain and precipitated a vigorous interchang 
between clinical investigators in neurochemistry and neurophysiology. 

It is conventional to divide the main classes of drugs used as therapeutic 
agents into three groups: antipsychotic drugs (those used in the treatment of 

major mental illnesses, including schizophrenia and related syndro: es such ^ 
paranoia and catatonia); antidepressant drugs, and antianxiety drugs. ><■ th 


129 


three classes of drugs described represent the main classes used as thera- 
peutic agents in mental illness, mention should be made of two other clinical 
states in which drug therapy has produced highly valuable results. Lithium 
has been successful in the treatment of mania and recurrent affective dis- 
orders, and psychomotor stimulants have had good results for hyperkinetic 
children with learning and attitudinal problems. 

We are at the end of the first wave of the drugs which include at least 
three main classes of drugs: 

1. The antipsychotic drugs include chlorpromazine, the prototypic 
drug, for the drugs used for psychoses, like schizophrenia, major 
paranoia; including thorazine and phenothiazines, etc. They have 
had major impact on the treatment of the serious mental illnesses. 

2. The second group are the antidepressants, the MAO inhibitors 
and the tricyclics. There is evidence that their proper use 
will reduce the suicide rate and contribute to a reduction in 
use of hospitalization and to shorten periods of hospitalization. 

3. The third group, which accounts for the largest number of 
prescriptions, are the antianxiety drugs. Librium and valium 
are two of the three most widely prescribed drugs in the world. 

There are some semantic problems to be clarified. Although there is 
imprecision about the use of the term antipsychotic for this category of 
drugs, it has a considerable advantage over the initially advocated term, 
"tranquilizer," which unfortunately, since 1950, the lay press has tended 
to emphasize. The word tranquilizer is now seen as a misnomer since it 


130 


implies utility only in patients who are excited and requiring calming. 
Experience has shown that these drugs have significant effects upon disturbed 
thinking as occurs in schizophrenic psychoses, but that they are unlikely to 
influence significantly any excitation and overactivity without the presence 
of disturbed thinking. 

Widespread usage distinguishes major tranquilizers, such as the pheno- 
thiazines, from the minor tranqui 1 izers , such as the meprobamate series and 
the diazepoxide derivatives. This latter group is related more closely to 
the sedative-hypnotics than to anti psychotics such as the barbiturates. The 
major tranquilizer minor tranquilizer distinction is inadequate and inaccurate. 
It implies that the meprobamate-barbiturate group is basically similar to the 
phenothiazine group, but contains weaker pharmacologic compounds. This is 
not accurate and it is far better to see these two classes of compounds as 
qualitatively different. 

The most rapid increase in drug use has been in antianxiety drugs, such 
as valium, librium and mil town. From 1964 to 1974, their popularity jumped 
from 45 million to over 110 million (generally refillable) prescriptions 
yearly. The use of antidepressant drugs such as elavil, antipsychotics such 
as stelazine and thorazine, and hypnotics such as the barbiturates, has 
increased a little, but not much. Valium, darvon (actually a pain drug, not 
a tranquil i zer) and librium are now the three most prescribed drugs in the 
entire world and valium the single most prescribed compound in the U.S. In 
any given year, twenty-two percent of the adult population of this country 
uses some prescriptive psychoactive drug, 9 % use at least some over the 
counter psychoactive drug, and 14 % admittedly increase their alcohol consumption' 


131 


as a means of coping with distress. Most of the prescriptions are written 
by general practitioners, not by psychiatrists, but they are mostly pres- 
cribed for psychological problems. Even considering the overlap, 30 to 40> 
of the adult population, over 20 million adults, and up to 25fi of the total 
population of the United States uses some chemical compound to ease psycho- 
logical distress in any one year. And there is little doubt, in terms of 
statistical projections, that it will increase for the foreseeable future: 
the more so if, as pharmacologists predict, today's drugs will be rendered 
obsolete by more potent and specific ones tomorrow. This has not happened 
Decause physicians are too ready to prescribe pills. The evidence is that 
Dhysicians are not always happy about dispensing these drugs, or, for that 
natter, about treating these patients, but often they do not know what else 
to do with them. People want relief from their distress, expect the physi- 
cian to help them find it, and leave the physician, therefore, feeling that 
there is little else they can do than prescribe, like it or not. 

It is not just physicians who are anxious about these drugs. A vocal 
group of social critics views their increasing use, with moral alarm, as "the 
over-medication of our society." The over-prescription of these drugs, they 
contend, tends to undermine the moral fiber of the nation by the "mystification 
of personal problems and interpersonal difficulties," so that people are en- 
couraged to evade their problems by happy pills, instead of coping with their 
problems by confronting them. 

Non-therapeutic Uses 

If there is a case for alarm over the statistics on drugs as medication, 
then there ought to be a red alert, if not a downright panic, over mood changing 


132 


drugs in general, because so far, we have been talking only of medical psy- 
chotropic drugs. The statistics report less data about use of coffee, tea, 
alcohol or marijuana - that is, the pleasure drugs. Not only is it clear 
that the pleasure drugs are being used at one time or another by up to half 
the adult population - but that their use is rapidly becoming decriminalized. 
One reason for this trend is that there is increasing knowledge and admission 
that the harmful effect of these drugs is overrated. Huxley noted that a 
medical commission appointed by New York's Mayor LaGuardia report, in 1944, 
that marijuana was not a menace, but just a nuisance. The same conclusion, 
it seems, was reached by a British commission as early as 1894, by British, 
American, and Canadian commissions in 1968, 1970 and 1972, respectively , and 
by the Consumers Union in 1972. 

More important that the facts reported by these commi ssions , for oury 
purposes, is the fact of the swell of reports themselves, reflecting the 
personal experience of millions of people who have used the drugs and not 
felt that the effects were bad ones. These events will produce the legali- 
zation of marijuana for the same reason, finally, that social events pro- 
duced the lifting of Prohibition. The Talmud warned, almost two thousand 
years ago, against making a law that the community cannot live with. The 
prohibition of alcohol was such a law; the civil disorder that resulted from 
it wa s so great, relative to whatever gains may have accrued from it, that 
the law had to be repealed. Alcohol ijs a poison and, by comparison with 
marijuana, a menace not just a nuisance. But people would not accept its 
prohibition; and the same thing is probably true of marijuana. The fact 
that many people want these drugs means that they are likely to get them, 


133 


sooner or later, which means in turn, for drugs that are legal and acceptable 
to begin with, that the market is likely to go on expanding. And in these 
facts lie the biggest coming policy issues of mental health technology: people 
want what they value and try to get what they want. In a society whose economy 
develops products and distribution facilities in approximate response to people's 
apparent values, the direction of the drug industry seems highly predictable. 

In a work-oriented society, people use stimulant drugs more than pleasure 
drugs. So coffee and tea and tobacco have long dominated the West, and hashish 
and opium have been more prevalent in the Orient. And people use anxiety 
reducing drugs in societies where stress produces anxiety, which is everywhere, 
but even more so in societies which create conflict within people's internal 
value systems. In our society, the expansion of all kinds of drug use may be 
a response to a growing transitional value conflict between puritanical and 
hedonistic ethics, reflected in evaluations of drug usage as the clash betv/een 
what Harvard Psychiatrist Gerald Klerman calls "psychotropic hedonism versus 
pharmacological Calvinism." That may also be why the statistics of drug use 
across age groups, at least in California, are such that younger men use more 
stimulants, middle-age ones use more tranquil izers, and old people use more 
sedatives. The younger men want to keep up or get ahead, old people want to 
turn off and go to sleep, and the rest of us would like some peace and quiet. 

The ultimate issue here, in any case, is not the value of drugs, but the 
value of virtues. The same questions are addressed the same way, if less 
dramatically, by all the self-administered, self enhancing, non-chemical devices 
of behavior control technology. The most important of these are psychotherapy 
and behavior modification. 


134 


Psychotherapy and Behavio r Modification * 

Huxley did not name psychotherapy among ominous behavior control methods, 
and people tended not to think of it as a form of behavior control until around 
1960, when behavior modification started getting known. They are doing so now, 
quite appropriately , as behavior modification is rapidly becoming the dominant 
speciality within the psychotherapy industry. There is every reason to think 
that it will continue to grow, especially in the areas of self-help and self- 
control . Within the mental health establishment, Transcendental Meditation, 

Sex Therapy, Assertiveness Training and Biofeedback have become very popular. 
Outside the establishment, Erhard Seminar Training (EST) has become a mass 

marketing operation for conveying similar messages. The EST statement may be 

the most global: "Transform your ability to experience living." But each of 

the methods implies the same goal: "By mastering this technology, you will 

be a happier person," whether being happier means better able to satisfy a 
work ethic, or to perform better at something specific, or to feel better, in 
general, on whatever grounds. The dominant psychological technology in mental 
health is in what is called "behavior modification" or "behavior therapy." 

This is now the case, and it will be much more the case in the future. In 

this paper, we are not making any case in favor of behavior modification. What 

we are describing is that behavior modification presents a new technology, and 
like any new technology, is able to make advances because it can produce speci- 
ficity of analysis which the previous psychological therapies had not been able 
to do easily, efficiently, and effectively. 

* This section does not elaborate upon the various forms of psychotherapy , and 
other behavioral techniques, since these have been discussed in detail in a 
previous paper by P. London and G. Klerman "Boundaries Between Rcsearu!' and 
Therapy Especially in Mental Health" prepared for the National Commission in 
January, 1976. 


135 


The trend toward behavior modification is extremely pronounced. A student 
of London's reviewed issues of 75 English language journals specializing in 
psychotherapy between 1973-1975: the primary action was clearly in the field 

of behavior therapy. O'Leary and Wilson in 1974 published a book summarizing 
behavior therapy, now called behavior modification, and they said this about 
the literature. In 1951, two major psychology and two major psychiatry jour- 
nals between them carried four articles: in 1970, the same journals carried 

70 articles. Since 1963, six journals which are devoted to behavior therapy 
have come into existence, and two more are being opened in Europe this year. 
There now is at least one annual review volume on behavior modification and 
behavior therapy. 

Increasingly, behavioral methods are coming to dominate the professional 
field of psychological therapy, but they are part of what we consider to be 
a general trend for the expansion of the psychotherapies. We foresee an in- 
creasing market of consumers; a larger and larger set of followers, to whom 
unconventional therapies are increasingly acceptable, and personnel who are 
not professionals in the formerly established sense of the word. Some of these 
unconventional therapies are the direct outgrowth of professional psychological 
activities, such as hypnosis, gestalt methods, bioenergetics, transactional 
analysis, and bicfeedback. Many of these therapies are also susceptible to 
application by non-professionals, and many of them have given rise to different 
therapeutic devices that are being actively conducted by nonprofessionals. 
Bioenergetics, for example, has had spin offs in rolfing, in the Feldfries 
method, and in what you might call "touching-feeling-nude" encounters. 


136 


There are a number of other therapies that are very specific. These 
include sex therapy, assertiveness training, meditation, weight control, 
and EST, transactional analysis, biofeedback. They are very important 
because they are spin offs of the psychotherapy technology, but have great 
specificity. People can use these therapies for specific kinds of problems 
without committing themselves to the total psychotherapeutic encounter that 
was traditionally necessary with psychoanalysis. 

All these methods are, on any reasonable definition, "technologies": 
they are systematic ways of doing something specific. Their claim to speci- 
ficity is what promises to transform psychotherapy into a more or less effective 
technology, for the precise application of specific treatments to specific con- 
ditions is what has long been most missing (and most lamented) in much of psycho- 
therapy. Behavior modification, or action therapy, is the one new area of 
psychotherapy where specific new methods are being reported in the professional 
1 iterature. 

The most popular techniques, however, are not necessarily ones which fit 
the traditional notion of psychotherapy as a means of repairing functional 
disabilities, that is, as a means of healing. Like drugs, they can often be 
seen even more as a means of enhancing performance, or self-satisfaction, than 
of repairing dysfunctions. 

Also, like drugs, behavior modification not only provides technologies 
for "hedonic treatments," but ones that are cheap enough and specific enough - 
like sex therapy and assertiveness training and biofeedback - to be marketable 
in a depressed economy. If therapy is cheap, people can afford to buy it in 


137 


a depression; if it is specific, they may be willing to spend money on it 
anyway, because it holds so much promise of helping them. Assertiveness 
training is cheap and specific; sex therapy is expensive but specific; bio- 
feedback varies in both respects. (It is the least popular of the three.) 

Sex therapy and assertiveness training were both described in 1958 in 
Joseph Wolpe's early work, P sychotherapy by Reciproca l Inhibiti on, which pro- 
vided much of the professional impetus from which behavior modification was 
soon to grow popular. But neither treatment became very popular until a 
decade or more later and, as both proliferated (generally without Wolpe get- 
ting much credit), they seem to have evolved growth rates which compare 
favorably to those of drug use. There may be over four thousand sex therapy 
clinics in the United States now, not counting therapists who do not advertise 
it as their specialty, and assertiveness training, in schools and churches 
as well as clinics, is too popular, to count its teachers or its minors. 

It is not surprising, then, that psychotherapy and psychotropic drugs 
increasingly reflect the same contemporary value. They are both technologies 
that you can take or do, not only to make yourself stop feeling bad, but also 
to make yourself start feeling good - a quantum term, which always means "better 
than you felt before." The aim of these therapies is to reduce the discomforts 
and to increase the pleasures of a society. 

III. Impact on Mental Health Care System 

A number of changes in the mental health care system have come about 
in large part as the consequence of these new drugs and behavioral technology. 


138 


There have been some significant changes in the health care system that 
provide mental health services. There is very good documentation that there 
has been a significant shift from an emphasis on mental health as an inpatient 
to outpatient services. That the utilization of inpatient services for 100,000 
has remained fairly constant over the past 20 years, but outpatient services 
have gone up, both proportional ly and in absolute numbers. 

NIMH maintained data for over 20 years on the utilization of clinics and 
mental hospitals: V A, private, county, psychiatric units in general hospitals, 

and clinics. These data indicates that there is an overall increasein utiliza- 
tion. Adjusted for population increase, there has been a doubling of the pro- 
portion of the population using public mental health services from 1954-1974 
from 0.8% of the population to over 2 % in 1974. 

Interestingly, the importance of inpatient facilities has decreased relative 
to the growth in the total system. Inpatient episodes have remained fairly 
constant, at about 800 inpatient admissions per 100,000 of the population. 

Within the inpatient sector, there has been a steady decline in the relative 
importance of the public sector, the state and county hospitals and VA hospi- 
tals, a slight increase in the admissions to private hospitals and a marked 
increase in use of psychiatric services in general hospitals. Mental health 
services has become more pluralistic. The governmental "monopoly" on mental 
hospitalization has ended. To a great extent this has happened because of 
the considerable expansion in coverage for mental hospitalization by health 
insurance policies. The health consumer now has a choice of where to go for 
mental hospitalization, previously public mental hospital services were all 
that were available, except to the very wealthy. 


139 


The greatest increases in mental health services, both absolutely and 
relatively, have been in the use of outpatient facilities; child guidance 
clinics, after-care clinics, day centers, community clinics. A new type 
of facility - the community mental health center - has been created. These 
clinics service many patients and employ a lot of professionals. In 1972, 
over IX of the population - 2 million people - were treated in these clinics, 
averaging between 5 and 10 visits per year per person. Most of these clinics 
are supported by tax funds at the federal, state or local level. To a large 
extent, they have been successful in meeting the goals of the federal pro- 
gram by providing services to the urban poor, rural residents, and to Black, 
Puerto Rican and other disadvantaged segments of the population who, in the 
era studied by Hollingshead and Redlich, were not receiving mental health 
care except in the large public hospitals. 

In addition to these changes in utilization and structure of the health 
care system, there have been significant changes in manpower. Now and in the 
foreseeable future, utilization of services is increasing faster than the 
growth of the professions. Consequently, there is a shift in the balance 
between services provided by professions, and those provided by para-pro- 
fessionals and non-professionals. The non-professionals are increasing, both 
absolutely in number, and relatively in proportion to the professionals. How 
long these trends will continue, and at what point there will be a leveling off 
of tne growth of the mental health manpower fields, is not certain. 

Within the mental health professions, there will probably continue to 
be tension between the two dominant doctoral level professions, psychiatry 
and psychology, and we may well foresee public pressure to force a combination 


140 


or unification between these two professions. Mental health services are 
increasingly being incorporated into other service systems, including the 
educational system, prisons and other correctional institutions, military, 
and other organizations which are not primarily part of the health system, 
but which are increasingly making use of mental health services. 

I V . Areas of Public Concern 

Anticipating the continued growth of the use of these technologies, 
six areas of public concern can be identified. These are: 

1. The fear that these technologies which will be used for 
behavior control for political ends. More will be said about 
this below. 

2. Defining the scope of mental health services and the boundaries 
between health and religion, law, education and personal value 
choice. 

3. Ethical aspects of human experimentation in mental health 
research. 

4. Demonstration of relative efficacy and safety for these 
technologies when used for treatment. 

5. Cost effectiveness, and 

6. Developing a manpower policy, particularly for the relations 
between professionals and non-professional s, and, within the pro- 
fessionals, the relationship between psychiatry and the other 
medical specialties, as well as between psychiatry and clinical 
psychology, and between clinical psychology and the other branches 
of psychology. 


141 


Having identified these six areas, we will elaborate upon the first 
two in some detail, since they have the most far-reaching ethical 
and social implications. 

Behavio ral Control and Public Po l icy 

The concern that these technologies will lead to political consequences 
was, of course, prototypical ly expressed by Aldous Huxley, in Brave New Worl d. 
Drugs and behavior modification have not been used for the political manipula- 
tions Huxley feared. Even so, his concerns were reasonable ones, because the 
technologies involved do make it possible for some people to invade the liber- 
ties of others, controlling how they act, and also maybe, at some point, even 
how they feel. Most contemporary critics of these technologies are worried 
chiefly about how to resist incursions on personal liberty by controllers. 

This concern is part of the Western political tradition, namely, the resistance 
to tyranny. Most of the controversies , legal actions, and public policy debates 
and decisions over the past decade about drugs and other possible behavior con- 
trol technologies have been offshoots of that preoccupation. Congress, the 
courts, consumer protection organizations, public interest lawyers, profes- 
sional guilds, and thoughtful private citizens have all addressed aspects of 
the technology by which some persons control others. The main misuse to which 
they have been alert is that in which apparently benign uses of behavior con- 
trol, as in medicine, infringe on civil liberties. That such misuse is often 
unintentional makes it more insidious, not less dangerous. 

Public policy problems of defining and preventing the misuse of behavior 
control have arisen with every major kind of control technology, from psycho- 
therapy through drugs and implantations, and with every kind of captive or 


142 


catchable audience - children, the mentally retarded, prisoners, hospital 
patients, and research subjects. Some of the specific issues have been 
gross infringements, such as giving school children drugs to make them more 
manageable in class, or forcing prison inmates into operant conditioning or 
psychotherapeutic programs. Others have involved subtle questions, such as 
defining the difference between experimental treatments and established ones, 
so that the former can be surrounded with restraints that protect patients. 
The common problem is that of protecting the weak from the strong, so that 
they are not victimized by their inferior state. 

What Huxley and other social critics did not anticipate is that the 
biggest social changes engendered by drugs and behavior modification tech- 
nologies do not arise from what people can do to each other , though those 
political dangers are potentially real enough, but from what people will 
want to do to themselves. The social consequences of greatest potential 
concern in a benevolent, free, society, are not the impositions of malicious 
intentions and hostile restraints, but of benign intentions and amicable 
enhancements. It is amicable enhancement, so common in daily life that we 
take them for granted, that constitute the most important kinds of conse- 
quences of these technologies. They are matters of how people want to treat 
themselves because they are things which individuals want to do, or want done 
to them. The social and ethical problems which result are those of the incur 
sions these treatments make on society's values, for they challenge the tradi 
tion of Puritan ethics and move us further and further, faster and faster, to 
wards a hedonic, or pi easure-oriented ethic. This trend is resulting, as we 
believe, from the interactions of an improving technology for the self control 


143 


of mood and behavior with an abundant economy and a political tradition of 
relatively great individual liberty. The continuation of this trend will 
occur as long as those forces are operating. In that event, these techno- 
logies need badly to be understood, monitored, and regulated, because their 
further scientific development is not likely to be halted or undone. 

The Boundaries of Health and Mental Health 

If, as we indicate, the main issues raised by these technologies are 
not so much the political spectre of "behavior control," but rather the in- 
creasing capability for technology to enhance personal functioning, the resultant 
concern for society in the future will be to define the boundaries for health and 
mental health, particularly as drugs and psychotherapies encroach upon areas pre- 
viously regarded as in the province of religion, education, law and personal 
value choice. These issues have already become the subject of debate for medi- 
cation. Our society is in the midst of a debate as to whether or not we are 
an overmedicated society. Articles in newspapers and popular magazines, multi- 
ple discussion panels on television and at least three Congressional committee 
hearings have been devoted to public discussion of this topic. These public 
discussions have their counterparts within the mental health professions where 
there are continuing debates as to the proper role of medication in the treat- 
ment of psychiatric disorders in general and the specific role of antianxiety 
agents in therapy states of anxiety and depression. 

The critics argue that we are being an overmedicated society. (See, for 
instance, C. Muller's article in Science , "The Overmedicated Society: Forces 

in the Marketplace for Medical Care." Muller discusses the forces that might 
have led to such overmedication, and notes that many of the relevant issues 


144 


are exaggerated in the prescription of psychoactive drugs. Similarly, 
Lennard et al . noted that: 


As more and more facets of ordinary human conduct, inter- 
actions, and conflicts are considered to be medical pro- 
blems, physicians, end, subsequently patients become 
convinced that intervention through the medium of 
psychoactive drugs is desirable or required. 


They further state that: 


The pharmaceutical industry is redefining the relabeling 
as medical problems calling for drug intervention a wide 
range of human behaviors which, in the past, have been 
viewed as falling within the bounds of normal trials and 
tribulations of human existence. 


This issue has gained prominence, in large part, because of the misuse 
of prescriptions, and the use of psychoactive drugs, as described above. The 
issues raised by psychoactive drugs have their counterpart in the general con 
cern for the expanding use of all mental health services, and the possible 
need to better define the limits of mental health itself. 

Our reponses to this concern is that the definition of "illness" is 
itself a value, and is determined by social conventions. There is no fixed 
quantity of illness, particularly of mental illness, at any one time, at any 
one society. The definitions of illness and the extent of legitimate medical 
intervention, are variable and determined by at least three factors including 
1. the general social economic level of the society, as reflected 
in the wealth of the individual patients and clients, 
the available biomedical technology, in this case, medications 
and psychotherapy, and 


2 . 


145 


3. the general societal expectations and values around health and 
illness as they are perceived, defined and acted upon by the 
individual patient. 

In the modern era, particularly in industrial urban nations, these three 
factors all combine so as to constantly extend the definition of illness to 
include not only conditions which might produce death, severe disability, or 
even pain, but also distress, including psychological and emotional distress. 
Extending the duration of life is no longer the major task of the health care 
system, but improving the quality of life. 

Our conclusion, therefore, is that the definition of illness is a social 
definition, and that the limits to "illness behavior" are likely to expand 
with rising expectations. "Life, liberty and the pursuit of happiness" were 
promised to us by the Declaration of Independence, and it is fitting in this 
Bicentennial year to consider that the American public has come to regard 
this promise as now including the absence of anxiety, guilt, and insomnia. 

Not only is the health care system being called upon to assist in the removal 
of distressing symptoms, but increasingly to enhance our capacity for per- 
formance and happiness, as is evident when we consider the role of the health 
care system in the sexual revolution with regard to contraception, abortion, 
and the sexual psychotherapies. 

This situation we have described above, the expanding use of the health 
care system in a modern industrial urban society, is not without its critics. 
If these critics prevail, rather than these matters being dealt with as part 
of the health care system, alternative institutions, such as law, religion, 


146 


or education, would be the proper focus for resolution of personal behavior 
conflict and reduction of emotional tension and psychic distress. 

Nevertheless, our prediction is that the health care system will continue 
to be the locus for technology development and service delivery in this area. 
The conventional institutional supports that societies have relied upon since 
the Neolithic revolution are: the family and extended kinship, the church, 

and the residential neighborhood. Modern urban and industrial society, with 
its high geographic mobility and secular orientations to the meaning of life, 
utilizes these traditional institutions less and less for social support, for 
provision of meaning to life, and for consolation for death, pain, disability, 
and loneliness. Given the prevalence of distress in human experience, where 
will people turn? The extended family ties are less available. Religion is 
less valued. The church has fewer resources as an institution. Geographic 
mobility means fewer friendships and neighborhood supports. But the health 
care system is there. It is scientific. It is secular. It has financial 
base for support - namely, the insurance system. It is effective. It has 
technology. 

V. Public Policy Mechanisms 

Public policy mechanisms can either enhance and facilitate these trends, 
or they can restrict, regulate or control the development and application of 
these technologies. The society as a whole can exercise many options, parti- 
cularly through its various agencies, most notably. Congress and other legis- 
latures, but also through various executive agencies and budgetary allocations 


147 


We have identified three major areas where public policy decisions are 
likely to be made within the next few decades. In identifying these areas, 
we have assumed that the trend to include drugs and behavioral technologies 
within the overall health system will continue. It is, of course, possible 
that this basic pattern will be reversed, and that "health" will no longer 
be the umbrella within which drug treatment and behavioral treatment for 
emotional problems are legitimized. Nevertheless, assuming the continued use 
of the health system, the following mechanisms are likely to emerge: 

1. Most important is the likely inclusion of mental health services 
within national health insurance. The major determinant of ' the extent 
to which the boundary of mental health services enlarges will be the 
extent of coverage under health insurance. This will include the 
nature of services covered, both drugs and psychological services, 

and the type of practi tioners, medical and non-medical, who are eli- 
gible for reimbursement . The rate at which national health insurance 
expands over the next few decades to include what are now considered 
to be "minor disorders" of neurotic distress and emotional problems, 
will probably be the main consideration in determing the rate at which 
health encroaches upon areas now regarded as legal, educational or 
rel igious. 

2. Next there is the development of a long term manpower policy. It 
is likely that there will be licensing of various kinds of psychothera- 
peutic professionals, comparable to that now provided for M.D.'s. The 
continued separation of psychology from medicine may result in pressure 
from the public at large for a combining of clinical psychology and 


148 


psychiatry into a new profession. This is a major policy decision, 
comparable to the efforts of the 19th century to combine the various 
medical practitioners. Another area of manpower mechanism will evolve 
around the extent to which financial and other support is provided for 
the further development of paraprofessional and non-professional types 
of mental health personnel. 

3. Finally, there is the possible development of a national therapeutic 
board, as has been discussed elsewhere in the body of this Report. The 
extension of the powers of such a board to review the evidence for the 
efficacy and safety of behavior therapy, psychotherapy and other forms 
of behavior modification, along with psychoactive drugs, would provide 
a powerful impetus to quality research in this field, and to increase 
scientific basis for methods of behavioral therapy. 

VI . Cone! usions 

Our analysis of mental health technologies had led us to conclude that these 
policy decisions about the mental health services can provide a quasi -experimental 
approach to testing the hypotheses that: (1) health and illness are essentially 

social conventions, and (2) the health care system is increasingly called upon 
to deal with the quality of life rather than its prolongation. 

II ^ 

Our forecast is that, as our society becomes more urban, more industrial, 
more mobile, more secular, and more individualistic, the health care system 
in general - and the mental health care system in particular - will be called 
upon more and more to deal with problems which were previously regarded as 


149 


social, legal, or even moral. In this expansion of the health care system, 
medication, psychotherapy and other behavioral technologies will be ever more 
widely used as means of coping with distress, enhancing performance, and 
improving the quality of life. The goals of the health care system tradi- 
tionally emphasized reduction of death and disability, and also relief of 
distress. It is the extension of the definition of "distress" that leads to 
the moral criticism. In the past, distress involved intense pain, as in 
broken limbs and abdominal catastrophies , etc. However, in the current era, 
the definition of distress has been broadened to include emotional complaints 
and psychic misfortunes, including anxiety, tension, insomnia, etc. In 
addition to the relief of distress, there is greater concern with the enhance- 
ment of performance, and the improvement of the quality of life, not only in 
mental health, but throughout health in general. 

All members of the population are potential consumers of mental health 
services. Given the definition of illness under the WHO criterion, most 
children could use help with furthering his/her personal, physical, psycholo- 
gical, cognitive, and emotional development. Most adults would like to be 
relieved of tension, guilt, insomnia. We would all like the health care 
system to make us more sexually potent, more beautiful, more intelligent, 
live longer, and happier. The major scientific question is: do the health 

and psychological professions have the biomedical and behavioral technology 
to achieve these goals? 

The future probably will produce drugs and behavioral technologies which 
will promote memory, improve learning, increase sexual activity, decrease rate 
of memory loss, and enhance performance. The social question then will be not 


150 


what is morally right?" but, "is it effective?" "at what cost?" "is it safe?" 
what are the social consequences?" 


151 


APPENDIX 3 

Recombinant DNA - - Science as a Social Problem 
By Everett Mendelsohn, James Sorenson and Judith Swazey 

On July 15, 1976 The Cambridge (Mass.) Chronicle carried a banner head- 
line across all six columns of its first page: "Three Month Ban on DNA Re- 

search O'Kayed by Council." To the local citizen of Cambridge and to the 
scientific practitioner who read this headline, the meaning seemed clear. 

A City council made up entirely of lay persons had voted to ban one form of 
basic biological research for a limited period of time. One city councilor 
commented at the time that had a public vote been taken among the lay citi- 
zens of Cambridge, it would have been 99 to 1 in favor of the ban. To scien- 
tific observers there was the chilling specter of scantly educated public 
bodies directly tampering with the conduct of basic research. It is hard to 
imagine a more starkly constructed confrontation between what science has con 
sidered its prerogatives and freedoms in designing research, and what worried 
citizens consider as their right to protection against hazard. That this dis 
pute should be played out in the chambers of a local city council gives clear 
evidence of how far we are from having satisfactory procedures for discussing 
assessing, and deciding on the proper modes of interaction between scientific 
research communities and the various groups that make up the public. 

The case of recombinant DNA is a particularly interesting one, since 
there are very few examples in the history of science in which a moratorium 
has been declared in an area of basic research. (See below for discussion of 
the source of the initial moratorium and further discussion of the Cambridge 


152 


actions.) As witnessed in the recent history of cardiac transplantation, 
the calling of a clinical moratorium by physician-researchers themselves, 
or the imposition of a moratorium on their work by others, has occured with 
some frequency in the history of medical research, particularly when human 
subjects are involved. In the history of basic sciences, one of the few 
other examples that bear any similarity to the case of recombinant DHA was 
the attempt of some atomic scientists in 1939 to keep tight secrecy around 
all work pertaining to nuclear chain reactions. The eifects of such secrecy 
would, of course, have been a dramatic slowing of progress in this area of 
basic research. The scientists recognized then that such secrecy and implied 
moratorium ran counter to the deepest traditions of science, and the plan failed 
to secure wide acceptance and was fairly quickly abandoned. Ihese traditions 
include the largely unstated assumptions that the goals and guidelines of basic 
research are developed almost wholly within the scientific community, and 
that the ability to carry out basic research in an unrestricted manner is 
closely linked to the very bases of successful science and the fundamentals 
of academic freedom. 

Just as the concern for the implications of a sustained chain reaction 
were first voiced from deep within the scientific community — indeed, it was 
only those with substantial knowledge who could raise question -- so, too, 
concern about the hazards of experimentation with recombinant DMA came ini- 
tially from those very scientists who were most directly connected with the 

potential research. 

The issue arose through the development of techniques permitting the iso- 
lation and rejoining of segments of DMA, which would then allow for the 


153 


construction of biologically active recombinant DMA in living cells. The 
fact that the major host for such experiments involved E. col i , a bacterium 
which resides in the human intestine, added to scientific concern. The 
several groups of scientists who were conducting the research believed that 
their breakthrough would lead to an ability to create recombinant DNA mole- 
cules from a variety of animal, bacterial, and viral sources. They were 
aware that the outcome of such research could well lead to very important 
theoretical and practical advances. But they realized too that they might 
breach the long processes of evolution, creating novel types of DNA that 
could be highly infectious and/or have biological properties that could not 
be fully predicted in advance. 

During the summer of 1973, a group of scientists attending the Gordon 
Research Conference on Nucleic Acids expressed concern about the scientific 
advances that they were witnessing and requested that the National Academy 
of Sciences undertake exploration of the issues. A copy of the letter to 
the Academy by M. Singer and D. Soil was published in Science (Vol . 181, p. 

114, 1973), and was thus first brought to the attention of the larger scien- 
tific community. The Academy established a committee that was chaired by 
Paul Berg, Chairman of the Department of Biochemistry at Stanford University, 
and included ten other scientists close to research in the field. 

After a good deal of internal give and take, as well as personal "research 
soul searching," the Berg Committee made a series of important recommendations. 
First, they urged ''scientists throughout the world" to "join with the members 
of this committee in voluntarily deferring" a series of experiments. In the 


154 


interim, they wished to examine "the potential hazards of such recombinant 
DNA molecules" and to develop adequate methods "for preventing their spread." 
Secondly, they called for a very careful weighing of any "plans to link frag- 
ments of animal DNA's to bacterial plasma DNA or bacterial phage DNA." For, 
they warned, experiments which joined a foreign DNA to a DNA replication system 
would "create new recombinant DNA molecules whose biological properties cannot 
be predicted with certainty." 

The Committee, thirdly, requested the Director of the National Institutes 
of Health to consider the establishment of an advisory committee whose tasks 
would be to oversee "an experimental program to evaluate the potential biolo- 
gical and ecological hazards" of the experiments noted above; to develop pro- 
cedures to "minimize the spread of such molecules within human and other popu- 
lations"; and to establish "guidelines to be followed by investigators working 
with potential hazardous recombinant DNA molecules." Finally, the Berg Commit- 
tee called for an international meeting of relevant scientists from all over 
the world, to be convened early in 1975 to review scientific progress in this 
area and to further discuss appropriate ways to deal with the potential bio- 
hazards of recombinant DNA molecules. 

The Report of the Committee on Recombinant DNA Molecules was a cautious 
one, which attempted to strike a note of realism and moderation. The Committee 
explicitly noted "that adherence to our major recommendations will entail post- 
ponement or possibly abandonment of certain types of scientifically worthwhile 
experiments." They also noted the difficulty of the evaluative tasks that they 
were suggesting. 


155 


It is worth making explicit what the Berg Committee did and did not deal 
with. Their interest was limited specifically to certain selected types of 
recombinant DNA experimentation, and their call was for a temporary halt in 
certain types of research and a careful review before other types were under- 
taken. Their interest did not extend to broader questions about the potential 
applications of these and other types of genetic experiments, for purposes 
such as biological warfare or genetic engineering. Instead, they addressed 
the very specific and limited area of hazards to public health which might 
be created by genetically altered bacteria developed with their new technique. 

The discussions to date had taken place wholly within the context of 
the scientific community, and, indeed, the proposals of the National Academy 
of Sciences Committee bn recombinant DNA molecules asked only for further 
considerations and guidelines to be developed within the scientific community. 

The international meeting called for in the report from Berg's Committee 
met at Pacific Grove, California in March 1975, gathering at a Conference site 
called AsilGinar. The outcome of this international conference on recombinant 
DNA molecules met with mixed response. One prominent dissident DNA specialist, 
Erwin Chargaff, referred derisively to the "Council of Asilomar" where "there 
congregated the molecular bishops and church fathers from all over the world 
in order to condemn the heresies of which they themselves had been the first 
and principal perpetrators . " Judging the outcome in extremely negative terms, 
he went on to say this was probably the first time in history that the "incen- 
diaries formed their own fire brigade." Others within the community of experi- 
menters breathed something like a sigh of relief, thinking that they had come 
through a difficult period in which they had shown high responsibility and 
public concern. 


I 


156 


At the opening session of the Asilomar Conference, Nobel Laureate David 
Baltimore - a member of the NAS committee chaired by Paul Berg - reminded the 
more than 100 conferees from 17 countries why they had assembled. In so doing, 
Baltimore, like other researchers before and after, sought to segregate the 
scientific issues sharply from the ethical and moral issues. The Asilomar 
meeting, he said, was not being held to discuss such "peripheral" ethical and 
moral questions as whether genetic engineering should be done at all, and its 
possible applications for chemical and biological warfare. Rather, the Asilomar 
scientists were to find a strategy for recombinant DNA research that would 
"maximize the benefits and minimize the hazards of the future," and offer this 
strategy as guidance to governments, scientists, and "private individuals" 
around the world. 

The Asilomar Conference report was written by Paul Berg and four co-authors, 
and a summary was reported by the Executive 'Committee of the Assembly of Life 
Sciences of the National Academy of Sciences on May 20, 1975. The overall con- 
clusions of the report were: the moratorium cn research could be lifted; an 
assessment of potential risks could be made; and with proper precautions, faci- 
lities with varying degrees of physical and biological containment could be 
constructed within which the experimentation could be safely conducted. The 
only set of experiments to be deferred were those dealing with recombinant 
DNA derived from highly pathogenic organisms, DNA which contained toxinogens 
and, finally, large scale experiments using recombinant DNA's that are able 
to make products potentially harmful to humans, animals, or plants. The Con- 
ference also noted the possibility of developing a safer group of host organisms 
and vectors, or carrying organisms, and felt that continuous work in this area 


157 


would improve vector-host systems which might reduce the biohazards of re- 
search. Several additional areas of research not currently being conducted, 
which would be helpful to understanding problems of survival of laboratory 
strains of bacteriophages, were to be encouraged, as well as the work of 
monitoring various elements of experimentation. The Committee of Asilomar 
scientists, in sum, issued a report which opened by giving recognition to 
what they felt would be the "revolutionary" impact of recombinant DMA re- 
search techniques, and closed by proposing procedures for physical and biolo- 
gical containment which would permit research to proceed with appropriate 
safeguards. 

In one sense, the guidelines promulgated by the Asilomar Conference could 
be viewed as public policy, because they were accepted on a temporary basis as the 
guides which would govern the granting of research funds by the National Insti- 
tutes of Health and the National Science Foundation. The next formal steps 
within the scientific community were to be taken by an NIH advisory committee 
on recombinant DNA molecules, that had been appointed in response to the recom- 
mendations made by the original Berg Committee. Indeed, it was this NIH committee 
which had recommended ^hat the Asilomar guidelines be used as the basis against 
which to evaluate the funding of research. During the summer of 1975 the NIH 
committee, meeting in hoods Hole, Kassachuset ts, assessed, argued about and 
ultimately weakened the experimental guidelines. Responding to criticisms that 
the Woods Hole draft was too lax, the head of the NIH committee, DeWitt Stetten, 
appointed a second subconanittee to reevaluate and propose alternative guidelines. 

In February 1975, trie Director of Mill held hearings on the proposed guidelines, 
which had been revised by the second subcommittee in December. These hearings 


158 


represented the first, limited, public input into the NIH deliberations on 
recombinant DNA research. Despite some criticism that the guidelines v/ere 
not strict enough in their containment requirements, and questions about 
how they would be generally enforceable beyond researchers receiving NIH 
funds, they were promulgated on June 23, 1975 (see the Federal Register , 

July 7 , 1 976, Pt. 2, Vol . 41, No. 1, p. 31). 

In the months between the Asilomar Conference, the Woods Hole subcomit- 
tee meeting, and publication of the final revision of the guidelines, the 
character of the discussions altered markedly. Beginning with what seemed 
like the contained considerations of those directly involved in recombinant 
DNA research, arguments broadened to include sharp criticisms from such inside- 
outsiders as Erwin Chargaff and the "Genetics in Society" group of Scientists 
and Engineers for Social and Political Action (SESPA). There was also a 
foretaste of the public interest that was to come when the Senate Health Sub- 
committee chaired by Edward M. Kennedy of Massachusetts held hearings on public 
policy for recombinant DNA techniques in Washington, D.C. on April 22, 1975. 

The discussion begun within the scientific community was further joined by the 
public or its representatives on at least two university campuses, the Uni- 
versity of Michigan and Harvard University, during the spring of 1976, when re- 
combinant DNA research and facilities to house it became the focus of attention 
of University committees on research safety and policy. Then, the most stilting 
break in the internally contained discussions occurred when the issue of rcc. m- 
binant DNA research became the focal point for several meetings of the Cambnoge 
(Mass.) city council in late spring and early summer 1976. 


159 


Thus, even as the scientific community attempted through a series of 
internal subcommittee hearings of the NIH to define policy and guidelines 
for research, dissident groups within that research community and lay public 
groups moved the issues to a far larger forum than that envisaged by that 
first group of DNA researchers who had called for a research pause or mora- 
torium in 1973. Prior to the issuance of the NIH guidelines, formal public 
involvement was minimal at best, being limited only to the public members 
of the advisory committee to the director of the NIH and to those members 
of the public who could make their way to a brief advisory committee meeting 
(February 10, 1976) and testify as witnesses. 

What, then, are the issues raised by recombinant DNA research, and what 
are the proper bodies to evaluate and to resolve those issues? Members of 
the DNA research community and others among their scientific supporters at 
first seem shocked that an issue which seemed to rest on careful consideration 
of highly technical matters should break out of the scientific arena and become 
part of public and even political discourse. As the scientists focused on the 
issue, many of them wanted to draw the lines of consideration as tightly as 
possible, dealing principally or solely with the problem of "biohazards." Some, 
we have seen, wished to rule out discussion of what they saw as the "peripheral" 
considerations of ethics and morality -- e.g., whether recombinant DNA research 
should be conducted at all, because of the implications of these techniques for 
genetic engineering and biological warfare. Others in the scientific community 
expressed concern over whether the public could ever gain enough understanding 
about recombinant DNA research to make appropriate decisions. Still others 
saw a basic issue of intellectual and academic freedom, an issue of rights that 


160 


they felt scientists would lose if the public, whether informed or not, be- 
came involved in making decisions about the regulation of basic research. 

As discussion of recombinant DMA research has moved beyond the confines 
of the scientific community that both initiated that research and first sur- 
faced concerns about its possible hazards, it has become evident that a broad 
and complex range of issues demand scrutiny. That is, the task of assessing 
this research, and of deciding who should do the assessment, involves a 
benefit-risk calculus that involves far more than technical matters of research 
methods and biohazard containment procedures. One fundamental matter, of 
import not just to the scientific community, already has been alluded to: 

Do "we" -- contemporary society — still want to grant scientists their long 
held "rights" of autonomy, to develop and pursue basic research areas according 
to the dictates of their professional judgment? If the answer is no, as may 
be the case with recombinant DNA research, then who ough t to determine which 
avenues of research are pursued, under what conditions, and what are the impli- 
cations of this new governance for science? Answers to these questions rest on 
value judgments. And value judgments are invoked because, despite the belief 
of some scientists that one can separate questions about science from questions 
about ethics and values, science is not and never has been "value-free." 

Decisions about the pursuit of recombinant DNA research, by whomever they 
have been or will be made, involve assessments of various types of short-term 
and long-term benefits and risks. While it was the involved research community 
who first "went public" with this calculus, it is important to remember that 
they called only for a moratorium — a temporary cessation of certain types 


161 


of recombinant DNA research. That is, as the Asilomar Conference report made 
clear, these scientists' deliberations were premised on the conviction that 
they were engaged in work of revolutionary importance. Recombinant DNA re- 
search, they affirmed, oug ht to go forward; the questions were ones of pace 
and suitable precautions. It was only as the debate moved into more public 
forums, partly in response to criticisms about the nature of the Asilomar 
proceedings, that the question began to be voiced, "Should recombinant DMA 
research be done at all?" 

Both proponents and opponents of recombinant DNA research have articulated, 
with various degrees of clarity, the following types of questions about benefits 
and risks. (But, we would add, there has emerged no consensus among the factions 
as to satisfactory answers.) First, there are questions about benefits. Working 
with a fundamental research methodology such as the techniques developed for 
recombinant DNA, how accurately are we able to forecast the types of useful 
results, in terms both of fundamental knowledge and applications, that might 
be gained? Can we predict with certainty new research pathways that might be 
developed for the work? And can we tell the lengths of time that will be re- 
quired for the work to yield given results?- In brief, how good are we at 
assessing present and prospective benefits for a given area of basic research? 
Secondly, there are risks of a near and long term nature that may arise "from 
tinkering with evolution" or breaching natural genetic barriers. Who is compe- 
tent to define and estimate present biohazard risks, and how accurately can 
they do so? Thirdly, in a situation where there are short and long term recog- 
nized and potential risks and benefits, how shall we decide what types of experi- 
ments should be conducted and should not be conducted? How shall we decide what 


162 


physical and biological safeguards are necessary for experiments, and how 
shall we monitor the procedures of the ongoing experiments? And further, 
how shall we establish a calculus for projecting future implications, as 
contrasted with retrospective judgments on past and present problems? 

Fourthly, when it comes to ethical, social, and legal issues presented 
by fields such as recombinant DNA research and by the potential applications 
of that research, how shall we establish guidelines that transcend the nar- 
row issue of protection against biohazards, and instead focus on the broader 
responsibilities of science and scientists. Is post hoc adjustment or rehabi- 
litation enough, or is there a necessity for developing careful, predictive 
processes? 

Fifthly, should and can we establish enforceable guidelines, at local 
or national levels, to regulate any or all recombinant DNA research, when 
conducted by researchers receiving public funds, by the private sector, such 
as pharmaceutical companies, or by a biology instructor? And, if there are 
potentially grave hazards, what good is regulation in one country alone? 

What are the modes for discourse and possible regulation at an international 
1 evel ? 

The formal and informal groups and agencies that have become involved 
in the recombinant DNA discussion to date reflect the tangled web of inter- 
actions within and between science, government, and elements of the lay 
public. On the scientific side, the semi-formal Berg Committee and the 
Asilomar Conference group were joined by the statutory authority of the 
National Institutes of Health and its advisory panels and subcommittees, the 


163 


advisory groups on research safety and policy committees on University campuses, 
and various individual scientists voicing deep concerns about the research 
and about the ways it was being dealt with by the "science establishment." 

On the public side, the debate has been joined by such diverse agencies 
as the Board of Regents of the University of Michigan, the Dean of the Faculty 
of Arts and Sciences at Harvard University, the city council of Cambridge, 
Massachusetts (and the lay subcommittee on research hazards that they appointed), 
several congressional subcommittees, and semi-public and semi-private political 
action groups within the scientific community. That no resolution of the 
issues of near and long term risks and benefits have been achieved is apparent. 

And equally apparent is the current lack of any mechanism, or procedure, for 
encompassing the obviously conflicting interests of the numerous involved parties. 

In a headline on June 16, 1976, the Washington Star caught the picturesque 
view of the Cambridge scene: "Is Harvard the proper place for Frankenstein 

tinkering?" In many ways the Cambridge situation has been a perfect one in 
which to see all the elements of the enlarged debate acted out in public, in 
contrast to the University of Michigan, where the debate was confined largely 
to the academic community. There was the flamboyant mayor who has made a 
career of "defending the little people against Harvard": there was a city coun- 
cil long known for lively public debates that often involved the City's two 
major educational institutions, MIT and Harvard; and there was the all star 
cast of scientists on both sides of the issues. That cast included several 
Nobel Prize winners, who split on this issue, and a very active chapter of 
Science for the People, which included among its members, geneticists and micro- 
biologists of some standing. The controversy arose in the most conventional of 


164 


manners, when researchers in the Department of Biochemistry and Molecular 
Biology proposed that a new facility be constructed which would conform to 
the guidelines developed at Asilomar and further polished in the N1H. They 
planned to construct the laboratories in the already existing biological labora- 
tories, a sprawling red brick building, guarded by two rhinoceroses. Perhaps 
it is symbolic, with respect to this controversy, that the laboratories face 
out to Divinity Avenue and the old building of Harvard Divinity School, and 
back on to Andover Hail, the new quarters of the Divinity School. 

With the notable exception of Nobel Prize winner, George Wald, the mole- 
cular biologists favored the proposed research facility, and gave strong backing 
to the conduct of research on recombinant DNA. When the discussion came to the 
biology department where the facilities were to be located, the situation became 
more difficult. Although the proposal had passed a biohazards subcommittee, 
composed of scientists, some vigorous opposition developed among biologists at 
both the senior and junior level. A fairly stormy meeting of the Department was 
held, and although a vote would probably have favored moving ahead with the 
research, there was certainly no clear consensus. 

The next step was consideration by the University's committee on research 
policy. This committee held an open hearing to which all members of the Uni- 
versity were invited and at which the proponents and opponents of r' jombinant 
DNA research rehearsed their views. The perspectives expressed covered the full 
range, from those praising the research and its important potentials to those 
sharply critical of the biohazards which night be encountered, to others w! • 
raised the long term issue of involvement in research on genetic engineering. 


165 


Most of the discussants were from within the scientific community, including 
members from groups at MIT, Brandeis, Boston University, and the several hospi- 
tals in the area. The dramatic high point of the meeting foreshadowed what was 
to come, when a member of the Cambridge City Council arose, introduced herself, 
ar.d indicated that the Council was keeping a watchful eye on the activities at 
the University. As had been predicted, the University's Committee on Research 
Tolicy (made up almost entirely of natural scientists) submitted a positive recom- 
mendation to the Dean, who then authorized construction of a high safety level 
(P3 level) containment facility. 

Enter the City Council, which in early June put Harvard and MIT on notice 
that it was conducting a public hearing on June 23rd, to which scientists and 
the lay public were invited to present their views. On June 23, the Council 
opened its hearings in packed chambers; in attendance were representati ves of 
the major research facilities, as well as visiting officials from the NIH and 
the other agencies. The hearings, which were filled with vigorous argument 
and a good deal of humor, lasted until one a.m. and were then adjourned to meet 
again on July 7. One councillor commented that the two weeks between those 
sessions saw more intense citizen contact with council members than had occurred 
on any other single issue facing the city of Cambridge. The Council strategy 
clearly was to arrive at a compromise. It recognized its public responsibility 
and its role as representatives of the local citizenry. It realized its respon- 
sibilities under the public health and safety laws, which require it to pass on 
the safety of all manner of facilities, from gasoline filling stations to com- 
plex industrial plants. The Council also recognized that, by and large, it and 
the citizenry it represented were not yet knowledgeable enough about recombinant 


166 


DNA work to make a fully informed decision; but, on the other hand, they 
noticed that decision ‘there must be. 

What emerged was a combination of political compromise and plans for 
greater public involvement in science. The compromise took the form of a 
Council's decision to ask for only a three months' moratorium on recombinant 
DNA research, a request that was readily agreed to by the scientists involved. 

(A three month extension was later voted by the council as they awaited a com- 
mittee report.) A committee of scientists and lay people was established, 
the Cambridge Laboratory Experimentation Review Board, which was to hold 
hearing and present a recommendation to the Council for further action. At 
the other end of the spectrum, the Mayor, who envisages himself as the protector 
of the "little people" of Cambridge, invited the proponents and opponents of 
recombinant DNA work to take their palces in adjacent booths at the Saturday 
market in Kendall Square, Cambridge. The sight of the eminent scientists with 
shirt sleeves rolled up, digging in for a long session of public education 
with all comers, was a fascinating one, and added a new dimension to modes 
of handling disputes between scientists and the public. 

While the Cambridge situation might be seen as the microcosm of a much 
broader problem, one thing seemed clear to all the participants: in the final 

analysis, resolution of the issues raised by recombinant DNA research would not 
be solved in the context of a small group of universities and a relatively small 
city's elected council. For, the problem transcends those narrow boundaries, 
albeit the community focus provided one of the more interesting scenes for 
debate and interaction between experts and lay people. 


167 


In the course of the debates in Cambridge and those held in such other 
localities as Ann Arbor, Michigan and the New York Academy of Sciences, a 
variety of proposals were brought forward, each seeming to reflect to some 
degree the interests of one group or another. The City Council in Cambridge, 
for example, listened to a proposal that it recommend to the Nobel Prize 
Committee that they explicitly exempt work on recombinant DNA from Nobel 
Prize consideration, thereby lowering one pressure for intensive and speedy 
work at this time. The Nobel Prize winning biochemist, George Wald, pleaded 
for a general slow down in research, pointing out that, if the problem is 
an important one today, it will be equally important at some future time 
when greater precautions might be taken. Others suggested that the research 
be taken out of populated areas and conducted instead in remote facilities 
operated under conditions of extreme caution. In response to the complaint, 
that having to go long distances to conduct their research would be a great 
inconvenience to the scientists, one commentator noted that, given the scien- 
tists' claim of great benefits to humanity from the research, such a trip 
should not make that much difference. 

Another proposal was that there be a period of intensive research to 
find an alternate host or series of host organisms other than E. col i , which 
would be much less likely to infect humans or those plants and animals on 
which they depend, and would thereby lower the probability of producing humian 
harm. The estimate for developing the amount of knowledge needed to replace 
E. col i bacterium as the host organism ranged from two years down to six 
months. Another suggestion was that certain areas of research be ruled out 
at least for the present, so that the issue of hazard might be examined in 


168 


greater detail and under less pressure. 

The Cambridge City Council heard recommendations for moratoria ranging 
from the three months that were agreed upon to a period of two years, and 
some kept insisting on the need for putting off the research until some 
later date. The position of the organized research community at Harvard and 
MIT was that research should proceed within the guidelines established by the 
NIH, and thus taking place in containment facilities appropriate to the risks 
envisaged. There were some among the scientists who saw the whole discussion 
as downright interference in their work, and they just asked to be left alone. 
It was clear that none of these proposals by itself would make everyone happy, 
nor was it clear that any mix of them would leave any one of the participants 
happy. The outstanding question thus is, through what procedures could a 
decision be arrived at which would give real scope for public participation, 
while at the same time providing real care for the needs of science and experi- 
mentation? 

To the observer of the debates that have swirled around recombinant DNA 
research since 1973, one persistent tendency has emerged. In the course of 
the discussions, even those at the Cambridge City Council, the issue seemed 
to focus time and time again on the specific question of immediate biohazards, 
with some participants in the debates pointing to broader matters, such as 
whether the research should be done at all, and, if so, its longer term 
evolutionary and societal implications. The scientists have pointed either to 
the nature of the hazards and the difficulties of resolving them, or to the 
operational steps that could be taken to lower the risk of hazard and of 
potential harm. To the public participants in the debate, the issue was 


169 


brought back continually to what harm might be done to the community, the 
family, or the individual. 

On only one or two occasions, and generally within a political context 
that sharply questioned contemporary scientific activity, was the issue of 
genetic engineering ever raised. The concept that there might be some form 
of "forbidden knowledge," which neither the scientific community nor public 
bodies are yet able to deal with, never received careful attention. Thus, 
while we find from many sides a plea to establish modes for developing science, 
medicine, and technology in such form that its current actions do not lead to 
future harm, we seem not to have even an appropriate framework within which 
to discuss the issues involved. To the scientist, genetic engineering seems 
little more than an extension of existiny techniques for altering natural 
genetic patterns, while to the lay person genetic engineering seems so far 
from comprehension as to fall more nearly within the realm of science fiction. 

As the case of recombinant DNA makes apparent, areas of science generally 
thought to be within basic research, now and with some probability in the 
future, will raise questions of short term and long term public hazard. That 
the scientific community has the ability to spot issues of this sort has once 
more been demonstrated by the fact that some recombinant DNA researchers them- 
selves noted the danger, signaled it, and attempted to find the mode for reme- 
dial and preventive actions. It is also apparent that, particularly in those 
areas where science may have consequences for the public, some members of the 
public are no longer docile or willing to remain outside the framework or 
critical decision making. But equally apparent is the fact that there are at 
this point few procedures by which the public and the participating researchers 


170 


can join in the important discussions, evaluations, and forecastings that 
are part of the decisions of why, how, and when to proceed. The design of 
such procedures seems to demand high priority. 

Since the summer of 1973, as we have indicated in this brief chronicle, 
the range of issues perceived in recombinant DMA research, and the numbers and 
types of people dealing with those issues, have broadened considerably beyond 
the concerns voiced by the small groups of scientists at the Gordon Research 
Conferences. At this writing (November 1973), the subject of recombinant DMA 
research and how to deal with the issues it poses has generated a diverse array 
of scientific, political, public policy, and legal responses, at local, state, 
and federal levels. Among the scientific community, the rapidly expanding 
pace of recombinant DMA research is indicated by the establishment of a new 
journal, Gene , "an international journal devoted to gene cloning and recom- 
binant nucleic acids," to begin appearing in 1977. 

The NIH guidelines have been followed by a second document, one, to our 
knowledge, unique for a basic research activity: a draft Environmental impact 

Statement on recombinant DMA research, developed in accordance with the National 
Policy Act of 1969 (see the Fede ral Reg iste r, Sept. 9, 1976, p. 33426). In 
the Executive Branch of government, biologist Don:. Id Kennedy has been appointed 
as a consultant to the White House Office of Science and Technology Policy: 
one of his assignments is policies concerning guidelines for rev embir; r.l : 
research. And, in Congress, Senator Kennedy's Health Subcommittee again held 
hearings (in September) on the implications of recombinant DMA wot k, i 
particularly on the plans of private industry and government reseat h ■ s 
to conform to the NIH guidelines. 


171 


State governments and private groups, too, are becoming involved in the 
question of how widely applicable and enforceable the NIH guidelines are. 

The New York State Attorney General, for example, presently is considering 
how to control recombinant experiments in his state, whether by somehow 
requiring all researchers to comply with the NIH guidelines, or by imposing 
stricter regulations. And two of the country's largest environment law firms, 
the Environmental Defense Fund and the Natural Resources Defense Council, 
have petitioned the Department of Health, Education, and Welfare, asking the 
government to extend the NIH regulations to cover all laboratories doing 
recombinant DMA work, including private industry. 

As these instances of federal, state, local, and private initiative make 
clear, questions about whether recombinant DNA research should be pursued -- 
and if so, how, -- are far from settled, the expectation of the Asilomar 
conferees notwithstanding. And, complex as the situation is within the 
United States, it is evident that public policy, ethical, legal, and scien- 
tific "channeling mechanisms" must be developed not only within this country, 
but internationally as well. For, recombinant DNA molecules, and also the 
potential benefits and risks they carry with them, do not recognize geographic 


boundaries. 


172 


Brief Se lected SI bl log raph y on Re combinant DNA 


Auerbach, S. 1975. "And Man Created Risks," (Report of Asilomar conference), 
Post.* Sunday, March 9, pp. Bl , B4. 

Berg, P. et al . 1974. "Potential Biohazards of Recombinant DNA Molecules," 

(letter). Sci ence 185_ (July 26), p. 303 (See also News and Comment article 
in this issue). 

Chargaff, E. 1976. "On the Dangers of Genetic Meddling," (letter) Science 192 
(June ), p. 938. 

Crichton, M . The An d name d a _St ra in . 

Cohen, S. 1975. "The Manipulation of Genes," Sc ientific Amer . 233 , pp. 25-33. 

"Genetic Engineering," 1975. Hearings before the subcommittee on health of the 
Committee on Labor and Public Welfare. U.S. Senate, April 22. U.S. 
Government Printing Office. 

Gottlieb, C., and R. Jerome. 1976. "Biohazards at Harvard," Boston Phoenix, 
June 8, pp. 9-34 passim. 

Lappe, M,, and R.S. Morison, eds. 1976. "Ethical and Social Issues Posed by 
Human Uses of Molecular Genetics," Ann a ls N .Y. Academy of Sciences, 265 . 

Wade, N. 1975. "Recombinant DNA: NIH Group Stirs Storm by Drafting Laxcr 

Rules," Science 190 (Nov. 21), 767-69. 


1975. "Recombinant DNA: NIH Sets Strict Ru^es to Launch New Technology," 

Science 190 (Dec. IS), 1175-79. 

1976. "Recombinant DNA: Guidelines Debated at Public Hearing," Scjenco l 01 
(Feb. 27), 834-36. 


In addition to these and many other individual references on the r< - ' inant: 
DNA debate, those interested in this subject should be aware of the Rccoi hi nant 
DNA Project underway in MIT's Oral History Program. Under the direction of 
Professor Charles Weiner, the Project thus far has collected over 1,; ents 

and taped oral history interviews with 45 individuals, dealing with recu ' b inant 
DNA research. 


<t U. S. COVKRNM 














http://nlhlibrary.nih.gov 





U.S. Department of Health, Education, and Welfare 
DHEW Publication No. (OS) 78-0015